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 Hemorrhage/Bleeding (1888)

Event Date 05/04/2015

Event Type  Injury  

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.

Event Description

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.

Event Description

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.

Event Description

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.

• 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
• MDR Report Key: 7975840
• MDR Text Key: 124066365
• Report Number: 3005099803-2018-02617
• Device Sequence Number: 1
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• Combination Product (y/n): N
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2018

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: 10/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001501011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 10/05/2018; 10/25/2018
• Supplement Dates FDA Received: 10/24/2018; 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 49