MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068505110

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Erosion (1750); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Fibrosis (3167); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Localized Skin Lesion (4542); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is approximated to (b)(6) 2021, date when the device was implanted.Initial reporter name and address: this event was reported by the patient's legal representation.(b)(6).(b)(4).

Event Description

Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report #3005099803-2022-07890 for the associated device information.It was reported to boston scientific corporation that a obtryx ii system - halo and upsylon y-mesh were implanted on (b)(6) 2021.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, including, pelvic pain, vaginal pain, urinary issues, erosion, inflammation and foreign body reaction as well as the need for surgical revision.The patient claims to have suffered the following damages as a result of the implantation of the obtryx device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.

Manufacturer Narrative

Block b3: date of event is approximated to (b)(6) 2021, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Block h6: patient codes (b)(6) captures the reportable events of inflammation, unspecified kidney or urinary problem, unspecified mental, emotional or behavioural problem, pain, erosion and hypersensitivity/allergic reaction.Impact codes f12 and (b)(6) captures the reportable events of serious injury/illness/impairment and device revision or replacement.Block h11: blocks a1, a2, a5, a6, b5, b7, d6b, e1, h6, and h10 were updated based on the additional information received on february 21, 2023.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).The revision surgeon is (b)(6).The explanting surgeon is (b)(6).Block h6: patient code (b)(6) captures the reportable events of erosion and extrusion.Patient code (b)(6) captures the reportable event of unspecified kidney or urinary problem.Patient code (b)(6) captures the reportable event of unspecified mental, behavioral and emotional problem.Patient code (b)(6) captures the reportable events of groin pain and vaginal pain.Patient code (b)(6) captures the reportable event of allergic reaction.Patient code (b)(6) captures the reportable event of inflammation.Patient code (b)(6) captures the reportable event of nerve damage.Patient code (b)(6) captures the reportable event of dyspareunia.Impact code (b)(6) captures the reportable event of device revision procedure.Impact code (b)(6) captures the reportable event of device explant procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report #3005099803-2022-07890 for the associated device information.It was reported to boston scientific corporation that a obtryx ii system - halo and upsylon y-mesh were implanted on (b)(6) 2021.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, including, pelvic pain, vaginal pain, urinary issues, erosion, inflammation and foreign body reaction as well as the need for surgical revision.The patient claims to have suffered the following damages as a result of the implantation of the obtryx device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Additional information received on february 21, 2023.The procedures performed on (b)(6) 2021 were robotic sacrocolpopexy and transobturator tape midurethral sling placement to treat a patient with total vaginal prolapse and stress urinary incontinence.Findings include sling flush with urethra but off tension and prolapse reduced to proper anatomic position.There no immediate complications reported at the conclusion of the procedure.On (b)(6) 2022, the patient sought consult for a history of groin and pelvic pain following the transobturator tape sling.The patient also experienced voiding dysfunction and urinary retention secondary to a suspected contracted transobturator sling.The patient experienced suspected mesh complications as well.The patient underwent a vaginal exploration with removal of transobturator tape sling, and transvaginal urethrolysis with cystoscopy.Findings during exam under anesthesia confirmed the preoperative findings of good vaginal support.The sling can be palpated around midurethra.Intraoperatively, the sling was found to be at mid-to-distal third of the urethra, not contracted anterior to the urethra; however laterally, left side greater than right, the sling appears to twist through the obturator musculature.Upon further examination, the left side of the sling was noted to be folded as it traversed through the obturator internus musculature.The patient was under iv sedation as procedure was extremely painful to her as the physician was removing the mesh sling arms.The sling was transected, and then, the arm was separated at least 3/4 cm.Then, 2-3 cm of sling arms were removed x2 and sent to pathology as requested by patient.After the procedures, the patient was awakened in stable condition.On (b)(6) 2022, the patient sought consult for vaginal pain, and exposure of implanted mesh.The patient also experienced postoperative obturator neuralgia and dyspareunia.The patient underwent an exploratory laparotomy with excision of sacropexy mesh; retropubic dissection with excision of retropubic mesh; vaginal mesh excision, as well as bilateral groin exploration with mesh excision.The patient was placed in supine position, awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.There were no complications reported.

Event Description

Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report #3005099803-2022-07890 for the associated device information.It was reported to boston scientific corporation that a obtryx ii system - halo and upsylon y-mesh were implanted on (b)(6), 2021.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, including, pelvic pain, vaginal pain, urinary problems, erosion, inflammation and foreign body reaction as well as the need for surgical revision.The patient claims to have suffered the following damages as a result of the implantation of the obtryx device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Additional information received on february 21, 2023.The procedures performed on (b)(6), 2021 were robotic sacrocolpopexy and transobturator tape midurethral sling placement to treat a patient with total vaginal prolapse and stress urinary incontinence.Findings include sling flush with urethra but off tension and prolapse reduced to proper anatomic position.There no immediate complications reported at the conclusion of the procedure.On (b)(6), 2022, the patient sought consult for a history of groin and pelvic pain following the transobturator tape sling.The patient also experienced voiding dysfunction and urinary retention secondary to a suspected contracted transobturator sling.The patient experienced suspected mesh complications as well.The patient underwent a vaginal exploration with removal of transobturator tape sling, and transvaginal urethrolysis with cystoscopy.Findings during exam under anesthesia confirmed the preoperative findings of good vaginal support.The sling can be palpated around midurethra.Intraoperatively, the sling was found to be at mid-to-distal third of the urethra, not contracted anterior to the urethra; however laterally, left side greater than right, the sling appears to twist through the obturator musculature.Upon further examination, the left side of the sling was noted to be folded as it traversed through the obturator internus musculature.The patient was under iv sedation as procedure was extremely painful to her as the physician was removing the mesh sling arms.The sling was transected, and then, the arm was separated at least 3/4 cm.Then, 2-3 cm of sling arms were removed x2 and sent to pathology as requested by patient.After the procedures, the patient was awakened in stable condition.On (b)(6), 2022, the patient sought consult for vaginal pain, and exposure of implanted mesh.The patient also experienced postoperative obturator neuralgia and dyspareunia.The patient underwent an exploratory laparotomy with excision of sacropexy mesh; retropubic dissection with excision of retropubic mesh; vaginal mesh excision, as well as bilateral groin exploration with mesh excision.The sacropexy mesh was easily identified.It was not clear if this actually had been placed in the retroperitoneal space, as it seemed to be under tension, and was not again clearly retroperitonealized versus not with some fixation to the sigmoid colon.The surgeon carefully separated the adhesions between the sigmoid colon and the mesh, where the mesh was affixed to the sacrum.Decision was made not to remove this portion of the mesh, as the patient did not appear to have any symptoms from this, so the mesh was cut with scissors, and a small portion was left affixed to the sacrum.The surgeon carefully separated the mesh from the bowel to the level of the vagina, carefully separated the scar tissue overlying the mesh, and then was able to excise the entire portion of the mesh.In the retropubic space, the right arm was identified and dissected out.A similar dissection was done on the left.Some venous oozing occurred and two large pieces of surgicel were placed in the retropubic space, as well as surgiflo with thrombin.The area was then closed.The anterior wall of the vagina was opened and noted to be quite scarred down.Blunt and sharp dissection mobilized the vagina off the bladder.No vaginal portion of the tvt sling could be identified, but a portion of the tvt-o sling on the right side was identified and excised.A vertical incision was made in the left groin lateral to the labia majora, starting just below the insertion of the adductor longus muscle.The left side of the tvt-o sling was identified and was quite affixed to the pubic bone in this area.Eventually though with traction and both sharp and blunt dissection, the mesh came away and freely, completely intact.This incision was closed.A similar dissection was performed on the right side, and the right arm was also removed intact.All surgical sites were closed.The patient was placed in supine position, awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.There were no complications reported.

Manufacturer Narrative

Block b3: date of event is approximated to january 11, 2021, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).Block h6: patient codes e2326, e1311, e0206, e2330, e2006 and e0402 captures the reportable events of inflammation, unspecified kidney or urinary problem, unspecified mental, emotional or behavioural problem, pain, erosion and hypersensitivity/allergic reaction.Impact codes f12 and f1905 captures the reportable events of serious injury/illness/impairment and device revision or replacement.Block h11: blocks a1, a2, a5, a6, b5, b7, d6b, e1, h6, and h10 were updated based on the additional information received on february 21, 2023.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is (b)(6).The revision surgeon is (b)(6).The explanting surgeon is (b)(6).Block h6: patient code e2006 captures the reportable events of erosion and extrusion.Patient code e1311captures the reportable event of unspecified kidney or urinary problem.Patient code e0206 captures the reportable event of unspecified mental, behavioral and emotional problem.Patient code e2330 captures the reportable events of groin pain and vaginal pain.Patient code e0402 captures the reportable event of allergic reaction.Patient code e2326 captures the reportable event of inflammation.Patient code e0123 captures the reportable event of nerve damage.Patient code e1405 captures the reportable event of dyspareunia.Impact code f1905 captures the reportable event of device revision procedure.Impact code f1903 captures the reportable event of device explant procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5, h6, and h10 have been corrected based on the medical review received on march 15, 2023.Block h6: patient code e2006 captures the reportable events of erosion and extrusion.Patient code e1311captures the reportable event of unspecified kidney or urinary problem.Patient code e0206 captures the reportable event of unspecified mental, behavioral and emotional problem.Patient code e2330 captures the reportable events of groin pain and vaginal pain.Patient code e0402 captures the reportable event of allergic reaction.Patient code e2326 captures the reportable event of inflammation.Patient code e0123 captures the reportable event of nerve damage.Patient code e1405 captures the reportable event of dyspareunia.Patient code e2101 captures the reportable event of adhesions.Impact code f1905 captures the reportable event of device revision procedure.Impact code f1903 captures the reportable event of device explant procedure.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h10: this supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.

Manufacturer Narrative

Blocks a4, b5, b6, b7 and h6: patient codes and impact codes have been updated based on the additional information received on august 9, 2023.Block b3: date of event is approximated to (b)(6) 2021, date when the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is dr.(b)(6).The revision surgeon is dr.(b)(6).The explanting surgeon is dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable event of: e2006 - erosion and extrusion; e1311 - unspecified kidney or urinary problem; e0206 - unspecified mental, behavioral and emotional problem; e2330 - groin pain and vaginal pain; e0402 - allergic reaction; e2326 - inflammation; e0123 - nerve damage; e1405 - dyspareunia; e2101 - adhesions; e2313 - fibrosis; e1710 - skin lesion; e1007 - constipation which required medication; e1413 - persistent genital arousal disorder; e2402 - abdominal bloating.The following imdrf impact codes capture the reportable event of: f1905 - mesh revision procedure; f1903 - complete mesh removal.

Event Description

Note: this report pertains to one of two devices used with the same patient.Refer to manufacturer report #3005099803-2022-07890 for the associated device information.It was reported to boston scientific corporation that a obtryx ii system - halo and upsylon y-mesh were implanted on (b)(6) 2021.As reported by the patient's attorney, the patient suffered from chronic complications of mesh, including, pelvic pain, vaginal pain, urinary problems, erosion, inflammation and foreign body reaction as well as the need for surgical revision.The patient claims to have suffered the following damages as a result of the implantation of the obtryx device: past and future medical and incidental expenses, past and future physical impairment, past and future physical disfigurement, past and future impairment of relationships, past and future loss of earnings and impaired earning capacity, past and future emotional distress, past and future physical pain and suffering, past and future out of pocket costs, and past and future economic and special damages.Additional information received on february 21, 2023: the procedures performed on (b)(6) 2021 were robotic sacrocolpopexy and transobturator tape midurethral sling placement to treat a patient with total vaginal prolapse and stress urinary incontinence.Findings include sling flush with urethra but off tension and prolapse reduced to proper anatomic position.There no immediate complications reported at the conclusion of the procedure.On (b)(6) 2022, the patient sought consult for a history of groin and pelvic pain following the transobturator tape sling.The patient also experienced voiding dysfunction and urinary retention secondary to a suspected contracted transobturator sling.The patient experienced suspected mesh complications as well.The patient underwent a vaginal exploration with removal of transobturator tape sling, and transvaginal urethrolysis with cystoscopy.Findings during exam under anesthesia confirmed the preoperative findings of good vaginal support.The sling can be palpated around midurethra.Intraoperatively, the sling was found to be at mid-to-distal third of the urethra, not contracted anterior to the urethra; however laterally, left side greater than right, the sling appears to twist through the obturator musculature.Upon further examination, the left side of the sling was noted to be folded as it traversed through the obturator internus musculature.The patient was under iv sedation as procedure was extremely painful to her as the physician was removing the mesh sling arms.The sling was transected, and then, the arm was separated at least 3/4 cm.Then, 2-3 cm of sling arms were removed x2 and sent to pathology as requested by patient.After the procedures, the patient was awakened in stable condition.On (b)(6) 2022, the patient sought consult for vaginal pain, and exposure of implanted mesh.The patient also experienced postoperative obturator neuralgia and dyspareunia.The patient underwent an exploratory laparotomy with excision of sacropexy mesh; retropubic dissection with excision of retropubic mesh; vaginal mesh excision, as well as bilateral groin exploration with mesh excision.The sacropexy mesh was easily identified.It was not clear if this actually had been placed in the retroperitoneal space, as it seemed to be under tension, and was not again clearly retroperitonealized versus not with some fixation to the sigmoid colon.The surgeon carefully separated the adhesions between the sigmoid colon and the mesh, where the mesh was affixed to the sacrum.Decision was made not to remove this portion of the mesh, as the patient did not appear to have any symptoms from this, so the mesh was cut with scissors, and a small portion was left affixed to the sacrum.The surgeon carefully separated the mesh from the bowel to the level of the vagina, carefully separated the scar tissue overlying the mesh, and then was able to excise the entire portion of the mesh.In the retropubic space, the right arm was identified and dissected out.A similar dissection was done on the left.Some venous oozing occurred and two large pieces of surgicel were placed in the retropubic space, as well as surgiflo with thrombin.The area was then closed.The anterior wall of the vagina was opened and noted to be quite scarred down.Blunt and sharp dissection mobilized the vagina off the bladder.No vaginal portion of the tvt sling could be identified, but a portion of the tvt-o sling on the right side was identified and excised.A vertical incision was made in the left groin lateral to the labia majora, starting just below the insertion of the adductor longus muscle.The left side of the tvt-o sling was identified and was quite affixed to the pubic bone in this area.Eventually though with traction and both sharp and blunt dissection, the mesh came away and freely, completely intact.This incision was closed.A similar dissection was performed on the right side, and the right arm was also removed intact.All surgical sites were closed.The patient was placed in supine position, awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.There were no complications reported.Additional information received on august 9, 2023: on (b)(6) 2021, the patient came to office for a follow up post implantation.She was sent home on oxygen after the implant.Patient reported she was a bit sore.When she was not using the oxygen, she felt a bit more tired.In a progress note on june 21, 2021, when the patient underwent a robotic sacro colpopexy with sling placement on (b)(6) 2021 with resolution of pelvic organ prolapse and leakage, she also reported vaginal tightness and right inguinal pain.General assessment included no masses or tenderness palpable on bimanual exam, no evidence of prolapse recurrence, wounds clean/dry/intact with no mesh erosion or extrusion, no leakage with reduction with valsalva.In a letter of march 11, 2022, it was stated that she was pleased with the resolution of her groin and pelvic pain as well as obstructive voiding.She felt that she emptied her bladder completely and had not experienced any urinary incontinence.The patient was contemplating seeing an orthopedic surgeon for her hip pain, after the sling removed, she was no longer having any further hip complaints.Her pelvic examination reveals a well-healed vaginal incision and appropriate bladder and urethral support.There was no tenderness with pressure against her urethra.In an office visit on (b)(6) 2022, the patient reported she always feels like she was on her period.She had pelvic cramping, abdominal pain, and back pain.It was interfering with her life and was worse with exercise.Review of systems included fatigue, constipation, dyspareunia, pelvic pain, vaginal pain, skin lesions and dysphoric mood.The patient was called via phone on (b)(6) 2022, to let her know that her operative reports were reviewed.Her pain complaints most likely are being caused by the retained groin portions of her tvt-o sling.However, the sacropexy mesh may also be contributing to this.It was doubtful that the tvt sling is contributing to her pain.Patient needs a physical examination to confirm the source of her pain and discuss treatment options going forward.In a progress note on (b)(6) 2022, speculum exam revealed intact vaginal mucosa.Overall support was good with minimal apical descent.First-second degree cystocele was evident with valsalva.A single blue suture/mesh material was visualized and palpated at 3 o'clock in upper vagina.In a clinical note on (b)(6) 28, 2022 where the patient had mesh removal surgery, it was reported that the patient had a vaginal hysterectomy with bilateral uterosacral suspension and rectocele repair in 2008.The patient did relatively well with no significant pain complaints.The patient noted onset of a new pain, bilateral groin pain, right greater than left, also lower abdominal pain, crampy menstrual type pain.The pain was increased with physical activity.She denied any stress incontinence, but did note some urinary frequency, no significant dysuria.She also had new onset constipation.Pain had been getting progressively worse.The patient could not have intercourse secondary to the pain.She also noted some vaginal bleeding, and was concerned about a possible erosion.She did get some pain with sitting.She also noted some pgad (persistent genital arousal disorder) type symptoms.She noted pain radiating down her medial thigh, which alters her gait.She noted some initial decrease in pain post removal of a portion of the sling in (b)(6) 2022., but then her pain recurred.Vaginal pain became worse.She tried some pelvic floor physical therapy without benefit.She had ridden horses for many years but found this to be very painful and difficult.She tried amitriptyline with minimal benefit and stopped it secondary to side effects.The most logical next step in her treatment was removal of all of her mesh products.This would involve a retropubic dissection because the tvt sling did appear to become a pain generator as well, so a laparotomy would potentially be performed with a retropubic dissection, and removal of the mesh from this compartment, as well as removal of the sacropexy mesh attached to the vagina.Pelvic examination showed positive mesh exposure in the vagina consistent with the sacropexy mesh.Sacropexy mesh itself is palpable with some exposure, and it is also quite tender.Also, palpation of the retropubic portion of the tvt sling is also quite tender, as is the vaginal portion of the sling.Pathology final diagnosis on the specimen removed included skin and subcutaneous tissue with fibrosis, chronic inflammation, fibroadipose tissue with chronic inflammation, foreign body giant cell reaction and foreign body consistent with mesh.After careful consideration, the patient has opted to proceed with complete mesh excision with exploratory laparotomy, sacropexy mesh excision, retropubic mesh excision, followed by transvaginal mesh excision, and bilateral groin explorations with mesh excision.On (b)(6) 2022, postoperative complete mesh excision, the patient was sore but okay.She already noted some improvement from her preoperative pain complaints.On (b)(6) 2022, patient presented for her routine postop check from mesh excision on (b)(6) 2022.The patient had continued surgical pain.Some of her pre-existing pain complaints were somewhat improved.The patient seemed to note more pain on the right than left.She had not moved her bowels and was taking colace and discussed the need for a stronger laxative.She had no significant urinary complaints.She had noted some minimal spotting from the vagina.Abdomen was soft, flat, minimally tender, her pfannenstiel incision is healing well with no erythema or induration.Overall, postoperative exam was normal.On (b)(6) 2023, the patient presented with constipation, unspecified type and abdominal bloating.Constipation symptoms started after she had surgery with mesh in 2021.In a mesh removal in (b)(6) 2022, the patient was told this was stuck to the sigmoid and colon.Constipation continued and did not improve despite various laxatives.Constipation was improving with linzess 145mcg daily and magnesium oxide 400mg daily.Stools ranged from soft to loose followed by little pieces.No incomplete defecation.She often felt bloated before bowel movements which improved afterwards.No blood in stool.No changes in appetite or weight.Review of systems included negative for abdominal distention and positive for constipation.

• Brand Name: OBTRYX II SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16096729
• MDR Text Key: 306637563
• Report Number: 3005099803-2022-07889
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2023
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0026423681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/21/2023; 03/15/2023; 08/09/2023
• Supplement Dates FDA Received: 03/14/2023; 04/24/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White