MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

Model Number M0068302450

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

Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Prolapse (2475); No Code Available (3191)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) (b)(4). (b)(6). The complainant indicated that the device is implanted and 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 xenform was implanted during a pelvic floor reconstruction with xenform including cystocele repair procedure performed on (b)(6) 2015. The procedure was completed without complications. According to the complainant, the patient experienced sensation of bulge related to the posterior and apical vaginal compartments on (b)(6) 2015. A pessary was placed to treat the event on (b)(6) 2015 and (b)(6) 2015, and was subsequently removed on (b)(6) 2015 and (b)(6) 2015. On (b)(6) 2015, the patient underwent retreatment for prolapse including laparoscopic total hysterectomy, apical vault suspension, rectocele repair, and enterocele repair with xenform graft. During the procedure it was noted that there were severe left hemipelvic adhesions encompassing the left adnexal strictures including ovary and tube, creating significant scar tissue that the left ovary and tube were barely visible. The event resolved on (b)(6) 2015 and the patient was discharged on the same day. The event was assessed as probably related to the index procedure, and probably related to the study device.

• Brand Name: XENFORM
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TEI BIOSCIENCES INCORPORATED; 7 elkins street; boston MA 02127
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9112308
• MDR Text Key: 161714482
• Report Number: 3005099803-2019-04590
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2016
• Device Model Number: M0068302450
• Device Catalogue Number: 830-245
• Device Lot Number: 0001404013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/24/2019 Patient Sequence Number: 1