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	Pain (1994)
Date of Event	04/11/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study name: u9920 xenform a/a postmarket.The complainant indicated that the device is 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 tissue repair matrix was implanted during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair procedure on (b)(6) 2014.According to the complainant, the patient experienced spontaneous rectal pain of moderate severity on the same of the procedure after she was discharged.This event was assessed as probably related to muscle spasm, and moderate in severity.She was then prescribed with diazepam, hydrocodone, dulcolax, and citrate of magnes.The patient presented for follow-up on (b)(6) 2014.On vaginal and rectal exam, the patient was tender only at the right sacrospinous ligament with pain referring down to rectal area.There were no areas of induration, no abscess, no mesh exposure or infection and no suture or graft material in rectum.Suture placement at site of sacrospinous ligament may have irritated nerve causing the pain to rectal area.On (b)(6) 2014, she underwent a surgery to release the suture and the event of rectal pain resolved.

• 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: 7954493
• Report Number: 3005099803-2018-02616
• Device Sequence Number: 16525263
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• 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
• Report Date (Section B): 09/12/2018

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: 10/31/2016
• Device Model Number: M0068302470
• Device Lot Number: 0001401009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/10/2018
• 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: 60 YR
• Patient Weight: 99