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

Model Number	M0068302470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); No Code Available (3191)
Date of Event	01/06/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that a xenform device was implanted on (b)(6) 2007 for repair of rectovaginal fistula.As reported by the patient's attorney, the patient underwent additional procedures for fistula repair on (b)(6) 2010, (b)(6) 2010, (b)(6) 2010 and (b)(6) 2010 due to persistent rectovaginal fistula.Boston scientific has been unable to obtain additional information regarding the event to date.

• 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: 9841965
• Report Number: 3005099803-2020-00819
• Device Sequence Number: 2856000
• Product Code: FTM
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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: 12/31/2009
• Device Model Number: M0068302470
• Device Catalogue Number: 830-247
• Device Lot Number: 0701024R1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR