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	Pain (1994); No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2017, the patient experienced dyspareunia.She was treated with physical therapy and the event has not yet resolved.
Additional Manufacturer Narrative
Correction to: race.Patient identifier: (b)(6).Report source: study name: (b)(6).(b)(4).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 procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2017, the patient experienced dyspareunia.She was treated with physical therapy and the event has not yet resolved.Additional information received on july 28, 2020.The event of dyspareunia was present at the patient's baseline and has not worsened in frequency or severity.

• 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: 6892552
• Report Number: 3005099803-2017-02839
• Device Sequence Number: 3655822
• Product Code: FTM
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 08/25/2020

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: 09/30/2016
• Device Model Number: M0068302470
• Device Catalogue Number: 72920
• Device Lot Number: 0001404014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 09/25/2017
• Supplement Report FDA Received Date: 08/25/2020
• 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: 43 YR
• Patient Weight: 66