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

Model Number M0068317100

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

Patient Problems Prolapse (2475); Insufficient Information (4580)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021, the date when the patient had an extensive excision of vaginal mesh with labioplasty, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representative.The implant surgeon is: (b)(6).The revision surgeon is: (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.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit posterior was implanted during a transvaginal hysterectomy, posterior colporrhaphy, enterocele repair, perineorrhapy, insertion of mesh, and extraperitoneal vaginal colpopexy procedure performed on (b)(6) 2010, for the treatment of uterine prolapse, rectocele, enterocele, and perineocele.On (b)(6) 2021, the patient underwent extensive excision of vaginal mesh with labioplasty for the treatment of complications of vaginal mesh and rectocele.During the procedure, a 15-blade scalpel was used to make a vertical incision and began to sharply dissect the rectovaginal fascia and identify the previously placed mesh to the level of the vaginal cuff.A sharp dissection was performed, and attention was paid so as to not damage any vital structures.They then performed an excision at the mesh arms, leaving the mesh arms in place after freeing it both anteriorly and posteriorly to the level of the vaginal cuff.These arms were making their way to the sacrospinous ligament.They then secured any bleeding vessels.Her previously planned posterior repair will be delayed due to the fact that the physician feels it would be a compromised source of healing; therefore, the patient should be returned to the operating room for this procedure at a later date.Furthermore, the vaginal mucosa was trimmed slightly and closed with a running 2-0 vicryl stitch.A wedge resection of bilateral labia was closed with 3-0 vicryl was then performed.Hemostats were used to establish our area of removal and, using a 15-blade scalpel, a small wedge of labia was removed, then they approximated and closed the incision with 3-0 vicryl.The patient was awakened and transported to the hospital in stable condition.

• 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: 14672847
• MDR Text Key: 294879894
• Report Number: 3005099803-2022-03077
• 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: 06/13/2022

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: M0068317100
• Device Catalogue Number: 831-710
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/13/2022
• 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): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Race: White