MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317080

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

Patient Problem Perforation (2001)

Event Date 03/12/2009

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system device was implanted into the patient during an intraperitoneal vaginal approach to colpopexy using the uphold procedure, anterior colporrhaphy, mesh insertion for vaginal support with the uphold, and a cystoscopy procedure on (b)(6) 2009, for treatment of uterovaginal prolapse.The patient was found to have stage 3 uterovaginal prolapse during the procedure.According to reports, the uphold mesh's left arm actually buttonholed through the patient's right vagina; as a result, this arm was removed and put back in place without a buttonhole.Additionally, there was no evidence of bladder urethral injury and there was efflux of urine from the ureteral orifices bilaterally.The patient was taken to the post anesthesia care unit (pacu) in stable condition with clear urine coming from her foley catheter.As reported by the patient's attorney, the patient has experienced an unspecified injury as a result of the surgery.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2009, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2114 - used to capture the reportable event of uphold mesh's left arm actually buttonholed through the patient's right vagina.The following imdrf impact code capture the reportable event of: f12 - patient had filed a legal claim for injuries related to the device.

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• 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): 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: 16893792
• MDR Text Key: 314807175
• Report Number: 3005099803-2023-02261
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081048
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: 0PD8112405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Female