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

Model Number	M0068302450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Prolapse (2475); No Code Available (3191)
Date of Event	07/31/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9112308
• Report Number: 3005099803-2019-04590
• Device Sequence Number: 14168788
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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
• Operator of Device: Health Professional
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 58