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

Model Number M0068505001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Erosion (1750); Diarrhea (1811); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Vomiting (2144); Hot Flashes/Flushes (2153); Dizziness (2194); Urinary Frequency (2275); Depression (2361); Sleep Dysfunction (2517); Constipation (3274); Syncope/Fainting (4411); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 12/21/2009

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2011 was chosen as a best estimate based on the date the mesh was removed.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6) 2009.As reported by the patient's attorney, the patient experienced an unknown injury and underwent removal of the device on (b)(6) 2011.

Manufacturer Narrative

Additional information: blocks a1, a3, b5, e1 below, h6: patient code and impact code.Block b3 date of event: the exact event onset date is unknown.The provided event date of march 22, 2011 was chosen as a best estimate based on the date the exposed mesh was removed.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The exposed mesh was removed at: (b)(6).Block h6: patient code e2006 captures the reportable event of mesh erosion in vagina.Impact code f1905 captures the reportable event of exposed mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during an anterior colporrhaphy with graft + transobturator tape with obtryx + sacrospinous ligament fixation procedure performed on (b)(6) 2009 for the treatment of cystocele with stress urinary incontinence and vaginal vault prolapse.The patient had mesh erosion in vagina after the implant and underwent surgical intervention on (b)(6), 2011 for the removal of the exposed mesh.The distal edge of approximately 0.5 cm of the mesh was exposed and was then trimmed with metzenbaum scissors.The top two edges were oversewed together where now the rest of the mesh was buried and no exposed mesh was visible or palpable at this time.The patient tolerated the procedure well and went to the recovery room in stable condition.No complications reported.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during an anterior colporrhaphy with graft + transobturator tape with obtryx + sacrospinous ligament fixation procedure performed on (b)(6) 2009 for the treatment of cystocele with stress urinary incontinence and vaginal vault prolapse.The patient had mesh erosion in vagina after the implant and underwent surgical intervention on (b)(6) 2011 for the removal of the exposed mesh.The distal edge of approximately 0.5 cm of the mesh was exposed and was then trimmed with metzenbaum scissors.The top two edges were oversewed together where now the rest of the mesh was buried and no exposed mesh was visible or palpable at this time.The patient tolerated the procedure well and went to the recovery room in stable condition.No complications reported.

Manufacturer Narrative

Correction: a2: date of birth.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2011 was chosen as a best estimate based on the date the exposed mesh was removed.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The exposed mesh was removed at: (dr.(b)(6)) (b)(6) medical center.Block h6: patient code e2006 captures the reportable event of mesh erosion in vagina.Impact code f1905 captures the reportable event of exposed mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during an anterior colporrhaphy with graft + transobturator tape with obtryx + sacrospinous ligament fixation procedure performed on (b)(6) 2009 for the treatment of cystocele with stress urinary incontinence and vaginal vault prolapse.The patient had mesh erosion in vagina after the implant and underwent surgical intervention on (b)(6) 2011 for the removal of the exposed mesh.The distal edge of approximately 0.5 cm of the mesh was exposed and was then trimmed with metzenbaum scissors.The top two edges were oversewed together where now the rest of the mesh was buried and no exposed mesh was visible or palpable at this time.The patient tolerated the procedure well and went to the recovery room in stable condition.No complications reported.On (b)(6) 2014, the patient had an office visit concerning the symptoms of nocturia, urinary incontinence, urinary urgency, abdominal pain, pelvic pain, headache and irritable bowel syndrome.She was taking oxycodone 30mg five times per day without fail and fentanyl patch.Patient requested a prescription for fentanyl for break - through pain.She had a refill for oxycodone but not the fentanyl as the patient had been of patch over a month.Patient had a total of three bladder surgeries and had mesh placement.The pain started after the mesh was placed.She was scheduled for follow up for further treatment and management and was referred to a urology for pelvic pain.Additionally, it was reported that the patient had fallen once in the last year.On (b)(6) 2015, patient came for follow up with a history of prolapse repair and sling placement, and urinary tract infection.She was complaining of bladder pain, continued incontinence, vaginal pain, pelvic pain, urinary frequency, nocturia, feelings of urinary urgency, urinary loss of control preceded by a sudden urge, and physical exercise, cough and/or sneeze.The patient also had pain during intercourse.Review of systems showed patient had headache, nausea, vomiting, bloating, abdominal pain, bowel movement frequency has recently changed, diarrhea, constipation, hot flashes, dizziness, fainting, depression and sleep disturbances.

Manufacturer Narrative

Blocks b5, b7 and h6: patient codes have been updated based on the additional information received on november 11, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of march 22, 2011 was chosen as a best estimate based on the date the exposed mesh was removed.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The exposed mesh was removed at: dr.Block h6: imdrf patient codes e2006, e2330, e1002, e1405 and e1310 capture the reportable events of mesh erosion in vagina, pelvic pain, abdominal pain, pain during intercourse and uti.Imdrf impact code f1905 captures the reportable event of exposed mesh removal.

Manufacturer Narrative

Blocks a4, b5, b6, b7 and h6: patient codes and impact codes have been updated based on the additional information received on october 18, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of march 22, 2011 was chosen as a best estimate based on the date the exposed mesh was removed.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6).The exposed mesh was removed at: (dr.(b)(6).(b)(6).Block h6: patient codes e2006, e2330 and e1002 capture the reportable events of mesh erosion in vagina, pelvic pain and abdominal pain.Impact code f1905 captures the reportable event of exposed mesh removal.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during an anterior colporrhaphy with graft + transobturator tape with obtryx + sacrospinous ligament fixation procedure performed on (b)(6) 2009 for the treatment of cystocele with stress urinary incontinence and vaginal vault prolapse.The patient had mesh erosion in vagina after the implant and underwent surgical intervention on (b)(6) 2011 for the removal of the exposed mesh.The distal edge of approximately 0.5 cm of the mesh was exposed and was then trimmed with metzenbaum scissors.The top two edges were oversewed together where now the rest of the mesh was buried and no exposed mesh was visible or palpable at this time.The patient tolerated the procedure well and went to the recovery room in stable condition.No complications reported.On (b)(6) 2014, the patient had an office visit concerning the symptoms of nocturia, urinary incontinence, urinary urgency, abdominal pain, pelvic pain, headache and irritable bowel syndrome.She was taking oxycodone 30mg five times per day without fail and fentanyl patch.Patient requested a prescription for fentanyl for break - through pain.She had a refill for oxycodone but not the fentanyl as the patient had been of patch over a month.Patient had a total of three bladder surgeries and had mesh placement.The pain started after the mesh was placed.She was scheduled for follow up for further treatment and management and was referred to a urology for pelvic pain.Additionally, it was reported that the patient had fallen once in the last year.

Manufacturer Narrative

Blocks b3, b5, b6, e1: initial reporter title, first name and last name, and h6: patient codes have been updated based on the additional information received on august 2, 2023.Block b3 date of event: date of event has been approximated to (b)(6) 2009, the date mesh exposure was first noted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The exposed mesh was removed at: (b)(6).Block h6: imdrf patient codes e2006, e2330, e1002, e140, e1310 and e1311 capture the reportable events of mesh edge palp in the bladder, pelvic pain, abdominal pain, pain during intercourse, uti, and drainage was sometimes yellow and sometimes green.Imdrf impact code f1905 captures the reportable event of exposed mesh removal.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during an anterior colporrhaphy with graft + transobturator tape with obtryx + sacrospinous ligament fixation procedure performed on (b)(6) 2009 for the treatment of cystocele with stress urinary incontinence and vaginal vault prolapse.On an examination on (b)(6) 2009, patient did have a small little edge of the transobturator tape mesh that was exposed.It was trimmed down to where it was flush with the vagina and patient was given some premarin cream to use each night for a week and then three times a week for a month.Patient was to return in four weeks for reevaluation to see if it was back to where it should be.Patient presented back on (b)(6) 2010, after having an anterior repair with a tot back in the beginning of (b)(6) 2009.She was in once before and had a little erosion of the edge of the mesh.We clipped this at that time.She came back and said that her husband could still feel it.There was a little rough edge.It was then trimmed back even more where it was no longer palpable by finger.On (b)(6) 2011, patient was complaining of painful intercourse, drainage was sometimes yellow and sometimes green, and bleeding.Patient had more than two abnormal past pap smear results.Her last pap smear was on (b)(6) 2010.Patient was taking anti-depressive, estrogens, and other medications.The bladder was reported to be normal but had mesh edge palp.It was palpable from tot on the left side and planned to be trimmed or excised.Additionally, patient stated that she and her husband could feel something poky and was unable to have intercourse as her husband felt somewhat like tearing him apart.The patient had mesh erosion in vagina after the implant and underwent surgical intervention on (b)(6) 2011 for the removal of the exposed mesh.The distal edge of approximately 0.5 cm of the mesh was exposed and was then trimmed with metzenbaum scissors.The top two edges were oversewed together where now the rest of the mesh was buried and no exposed mesh was visible or palpable at this time.The patient tolerated the procedure well and went to the recovery room in stable condition.No complications reported.On (b)(6) 2014, the patient had an office visit concerning the symptoms of nocturia, urinary incontinence, urinary urgency, abdominal pain, pelvic pain, headache and irritable bowel syndrome.She was taking oxycodone 30mg five times per day without fail and fentanyl patch.Patient requested a prescription for fentanyl for break - through pain.She had a refill for oxycodone but not the fentanyl as the patient had been of patch over a month.Patient had a total of three bladder surgeries and had mesh placement.The pain started after the mesh was placed.She was scheduled for follow up for further treatment and management and was referred to a urology for pelvic pain.Additionally, it was reported that the patient had fallen once in the last year.On (b)(6) 2015, patient came for follow up with a history of prolapse repair and sling placement, and urinary tract infection.She was complaining of bladder pain, continued incontinence, vaginal pain, pelvic pain, urinary frequency, nocturia, feelings of urinary urgency, urinary loss of control preceded by a sudden urge, and physical exercise, cough and/or sneeze.The patient also had pain during intercourse.Review of systems showed patient had headache, nausea, vomiting, bloating, abdominal pain, bowel movement frequency has recently changed, diarrhea, constipation, hot flashes, dizziness, fainting, depression and sleep disturbances.

• Brand Name: OBTRYX SYSTEM
• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13593582
• MDR Text Key: 287205101
• Report Number: 3005099803-2022-00870
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: 08714729718994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: 0ML9062304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 49 KG