XENFORM SOFT TISSUE REPAIR MATRIX

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.

Description of Event or Problem

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.