XENFORM SOFT TISSUE REPAIR MATRIX
Received Oct 17, 2018 · Event occurred May 4, 2015
Report 3005099803-2018-02617 · MDR key 7975840
Device
Generic name
Mesh, Surgical, Non-synthetic, Urogynecologic For Apical Vaginal And Uterine Pro
Manufacturer
Boston Scientific - MarlboroughModel number
M0068302470Lot number
0001501011
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
SECONDARY/ALTERNATIVE PATIENT ID: (B)(6). STUDY NAME: U9920 XENFORM A/A POSTMARKET. THE COMPLAINANT INDICATED THAT THE DEVICE IS IMPLANTED AND THE DEVICE IS NOT EXPECTED TO 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 XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING APICAL VAULT SUSPENSION, VAGINAL APPROACH HYSTEROPEXY, AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING AND AFTER THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING WHICH REQUIRED BLOOD TRANSFUSION. THE EVENT RESOLVED ON (B)(6) 2015.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING APICAL VAULT SUSPENSION, VAGINAL APPROACH HYSTEROPEXY, AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING AND AFTER THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING WHICH REQUIRED BLOOD TRANSFUSION. THE EVENT RESOLVED ON (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 5, 2018. TO ADDRESS THE EVENT OF BLEEDING, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015 AND WAS DISCHARGED ON (B)(6) 2015.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT XENFORM SOFT TISSUE REPAIR MATRIX WAS IMPLANTED DURING A PELVIC FLOOR REPAIR PROCEDURE WITH XENFORM INCLUDING APICAL VAULT SUSPENSION, VAGINAL APPROACH HYSTEROPEXY, AND CYSTOCELE REPAIR PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING AND AFTER THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING WHICH REQUIRED BLOOD TRANSFUSION. THE EVENT RESOLVED ON (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 5, 2018 TO ADDRESS THE EVENT OF BLEEDING, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2015 AND WAS DISCHARGED ON (B)(6) 2015. ***ADDITIONAL INFORMATION RECEIVED ON OCTOBER 25, 2018*** ON (B)(6) 2015, ON POSTOPERATIVE DAY 1, THE PATIENT'S HEMOGLOBIN (HGB) WAS 7.7, DECREASED FROM HER PREOPERATIVE HGB OF 11.7. EXAM NOTES INDICATE THERE WAS NO ACTIVE VAGINAL BLEEDING, BUT THERE HAD BEEN 300 CC BLOOD LOSS INTRAOPERATIVELY ON (B)(6) 2015. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY LIGHTHEADEDNESS OR DIZZINESS AND HER VITAL SIGNS WERE STABLE. SHE WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELLS. ON (B)(6) 2015, THE PATIENT'S HGB WAS 9.9, AND ON (B)(6) 2015, HER HGB WAS 10.7. THE EVENT WAS RESOLVED ON MAY 6, 2015. THE BLEEDING WAS ASSESSED BY THE INVESTIGATOR AS NOT PELVIC FLOOR RELATED, PROBABLY RELATED TO THE PROCEDURE, AND NOT RELATED TO THE DEVICE. - THE LOCATION OF THE BLEEDING WAS THE SURGICAL SITE.