MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH XENFORM SOFT TISSUE REPAIR MATRIX; 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 Code	Incontinence (1928)
Date of Event	03/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Report source: study name: (b)(6).The complainant indicated that the device remains implanted and will not 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 soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2016, the patient experienced fecal incontinence.No treatment has been given and the event has not yet resolved.
Event or Problem Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2016, the patient experienced fecal incontinence.No treatment has been given and the event has not yet resolved.Additional information received on september 27, 2017 the event of fecal incontinence was resolved on (b)(6) 2017.
Event or Problem Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted during a pelvic floor reconstruction with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2016, the patient experienced fecal incontinence.No treatment has been given and the event has not yet resolved.Additional information received on september 27, 2017.The event of fecal incontinence was resolved on (b)(6) 2017.Additional information received on september 11, 2018.The correct onset date for the event of fecal incontinence is (b)(6) 2016.

• Brand Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Common Device Name: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6871541
• Report Number: 3005099803-2017-02752
• Device Sequence Number: 1364459
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: (01)08714729774198(17)20161130(10)0001312018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2017

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: Physician
• Device Expiration Date: 11/30/2016
• Device Model Number: M0068302470
• Device Lot Number: 0001312018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/27/2017; 09/11/2018
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/25/2017; 09/28/2018
• 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: 64 YR
• Patient Weight: 41