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

Model Number M0068502110

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Adhesion(s) (1695); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Urethral Stenosis/Stricture (4501); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 11/18/2016

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an advantage fit system was implanted during a transvaginal tape (tvt) and cystoscopy procedure performed on (b)(6) 2016, for the treatment of stress urinary incontinence.During the procedure, with the tvt sheaths still in, the guidewire was removed, and cystoscopy was carried out.The bladder was filled with 500ml of saline.The physician got a thorough look with 12 sweeps of the bladder, concentrating on the lateral aspects of the bladder.There was no injury, no tvt sheath in the bladder.The urethra was inspected thoroughly; there was no injury to the urethra.With the placement of the trocar behind the pubic bone, there was more blood loss than usual, with an estimated amount of 500ml.A weighted speculum was removed.A vicyl 2-0 gi needle was used to sew the vaginal epithelium closed.There was no bleeding coming out of the skin sites.The suprapubic incisions were closed with subcuticular vicryl.The bleeding slowed considerably as the physician closed the vaginal epithelium.Final check on the vaginal closure: there was no leaking through the closure site.The vaginal tissue space was not expanding.Hemostasis appeared to be present.The patient tolerated the procedure well.She went to the recovery area in stable condition.The patient will be watched overnight for excess blood loss.On (b)(6) 2021, the patient underwent advantage sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, and removal of abdominal mesh for the treatment of pelvic pain, dyspareunia (pain with coitus), urge incontinence, urinary tract infections, and urinary stricture.This was a very difficult surgery due to the scarring from previous surgery as well as the right sling arm being in the obturator internus muscle and densely adhered to the pubic bone and a very lateral exit location.The left sling was in the lateral urethral wall and bladder wall and was adherent to the pubic bone.The sling was deep in the urethral wall on the right and under tension.The previous advantage sling was identified under tension and freed from the scar tissue.The mesh was incised in the midline and dissected as far lateral as possible.The dissection was carried to the contralateral side.The paravaginal space was opened, and the mesh was felt with the scissors but was embedded in the bladder wall on the left and in the obturator muscle on the right.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.Attention was directed to the abdominal component.A traverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free, exposing the rectus muscles.Copious irrigation was performed.Hemostasis was excellent.The urethral and bladder walls were approximated with interrupted sutures of #3-0 dexon.The anterior vaginal wall was closed with a running suture of #2-0 dexon.The vagina was lightly packed with lodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).The revision surgeon is: dr.(b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Correction to blocks b5 and h6.Block b3 date of event: date of event was approximated to (b)(6) 2016, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).(b)(6) hospital.The revision surgeon is: dr.(b)(6).Block h6: patient codes e0506, e2330, e1405, e1310, e1307, e1715, e2101, and e211401 capture the reportable events of hemorrhage, major (500ml blood loss), pain (pelvic pain), dyspareunia (pain with coitus), infection, urinary tract, urethral stenosis/stricture, scar tissue (scarring from previous surgery), adhesions (right sling arm being in the obturator internus muscle and densely adhered to the pubic bone and very lateral exit location, the left sling being was in the lateral urethral wall and bladder wall and adherent to the pubic bone), and internal organ perforation (the trocar and sling were passed through the bladder and urethral walls), respectively.Impact codes f1903 and f19 capture the reportable events of device explantation (advantage sling removal, removal of abdominal mesh) and surgical intervention (urethral lysis, anterior colporrhaphy, abdominal paravaginal).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure 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 advantage fit system was implanted during a transvaginal tape (tvt) and cystoscopy procedure performed on (b)(6) 2016, for the treatment of stress urinary incontinence.During the procedure, with the tvt sheaths still in, the guidewire was removed, and cystoscopy was carried out.The bladder was filled with 500ml of saline.The physician got a thorough look with 12 sweeps of the bladder, concentrating on the lateral aspects of the bladder.There was no injury, no tvt sheath in the bladder.The urethra was inspected thoroughly; there was no injury to the urethra.With the placement of the trocar behind the pubic bone, there was more blood loss than usual, with an estimated amount of 500ml.A weighted speculum was removed.A vicyl 2-0 gi needle was used to sew the vaginal epithelium closed.There was no bleeding coming out of the skin sites.The suprapubic incisions were closed with subcuticular vicryl.The bleeding slowed considerably as the physician closed the vaginal epithelium.Final check on the vaginal closure: there was no leaking through the closure site.The vaginal tissue space was not expanding.Hemostasis appeared to be present.The patient tolerated the procedure well.She went to the recovery area in stable condition.The patient will be watched overnight for excess blood loss.On (b)(6) 2021, the patient underwent advantage sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, and removal of abdominal mesh for the treatment of pelvic pain, dyspareunia (pain with coitus), urge incontinence, urinary tract infections, and urinary stricture.This was a very difficult surgery due to the scarring from previous surgery as well as the right sling arm being in the obturator internus muscle and densely adhered to the pubic bone and a very lateral exit location.The left sling was in the lateral urethral wall and bladder wall and was adherent to the pubic bone.The sling was deep in the urethral wall on the right and under tension.The previous advantage sling was identified under tension and freed from the scar tissue.The mesh was incised in the midline and dissected as far lateral as possible.The dissection was carried to the contralateral side.The paravaginal space was opened, and the mesh was felt with the scissors but was embedded in the bladder wall on the left and in the obturator muscle on the right.A urethral lysis was performed with sharp dissection to further free the urethra and scar tissue.Attention was directed to the abdominal component.A transverse skin incision was made, and this incision was sharply taken down to the level of the fascia.The mesh was identified in the fascia and the fascia was incised around the mesh and the mesh dissected free, exposing the rectus muscles.The mesh was freed from the muscle tissue.The retropubic space was opened bilaterally to visualize the right mesh arm, progressive dissection completely freed the right sling arm from the obturator muscle.The vaginal clamp was released, and the entire sling arm was handed off the operative field.The left sling arm was identified and freed from the fascia and rectus muscles.Traction of the arm elevated the bladder wall.The mesh was followed and freed from the left bladder wall and was dissected off the bone and obturator muscle.The vaginal clamp was released, and the entire sling arm was handed off the operative field.The bladder wall was repaired with interrupted sutures of #2-0 dexon.The right sling arm was identified and freed from the fascia and rectus muscles.The mesh was followed and freed from right bone and obturator muscle.This was very difficult.The vaginal clamp was released, and the entire sling arm was handed off the operative field.Copious irrigation was performed.The fascia was closed with interrupted sutures of #0 dexon.Subcutaneous tissues were reapproximated with interrupted sutures of #2-0 dexon.A 19 f drain was placed in the subcutaneous space.Skin edges were reapproximated with staples.Hemostasis was excellent.The urethral and bladder walls were approximated with interrupted sutures of #3-0 dexon.The anterior vaginal wall was closed with a running suture of #2-0 dexon.The vagina was lightly packed with lodoform gauze packing.The foley was connected to gravity drainage.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.

• Brand Name: ADVANTAGE FIT 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: 15075681
• MDR Text Key: 296316622
• Report Number: 3005099803-2022-03982
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: 08714729772880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2019
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: 0000043970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female