MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317050

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

Patient Problem Insufficient Information (4580)

Event Date 08/06/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit device was implanted into the patient during a bilateral sacrospinous colpopexy, vaginal paravaginal repair with pinnacle mesh system, pelvic adhesiolysis, enterocele repair, right salpingo-oophorectomy, posterior colporrhaphy, suburethral sling with tension-free vaginal tape, cystourethroscopy procedure performed on (b)(6), 2010, for the treatment of vaginal vault prolapse, cystocele, rectocele, enterocele, and stress urinary incontinence plus significant pelvic adhesions.Postoperative findings are as follows: there is a significant scarification of the small and large bowel into the enterocele sac and the peritoneum.The left tube and ovary are encased in adhesions in the left pelvic sidewall and once these adhesions had been lysed the ovary and tube were still non-mobile and attached firmly to the pelvic sidewall risking ureteral injury if they were to try to remove it.The right tube and ovary were more mobile and were removed without difficulty.A fourth degree bulbous cystocele with some thinning of the muscularis wall requiring minor repair, second-degree rectocele, stress incontinence by preoperative urodynamic testing.The estimated blood loss for surgery is 400 ml.Reportedly, the patient tolerated the procedure very well.She was taken to recovery room in good condition.As reported by the patient's attorney, the patient has experienced an unspecified injury after the mesh was implanted.

Manufacturer Narrative

Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2010 was chosen as a best estimate based on the date of the mesh was implanted.The complainant was unable to provide the correct suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• 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: 15929649
• MDR Text Key: 304955719
• Report Number: 3005099803-2022-05240
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2022

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 Model Number: M0068317050
• Device Catalogue Number: 831-705
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female