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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/11/2014

Event Type  Injury  

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 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
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TEI BIOSCIENCES INCORPORATED; 7 elkins street; boston MA 02127
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7954493
• MDR Text Key: 123356592
• Report Number: 3005099803-2018-02616
• Device Sequence Number: 1
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: M0068302470
• Device Lot Number: 0001401009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 99