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 Problems Unspecified Infection (1930); Dysuria (2684)

Event Date 03/26/2017

Event Type  Injury  

Manufacturer Narrative

The complete patient id is (b)(6).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 used during a pelvic floor repair procedure with xenform procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2017, the patient experienced dysuria.The patient was treated with ciprofloxacin and the event resolved on (b)(6) 2017.The investigator assessed the event as moderate in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair procedure with xenform procedure performed on (b)(6) 2015.According to the complainant, on (b)(6) 2017, the patient experienced dysuria.The patient was treated with ciprofloxacin and the event resolved on (b)(6) 2017.The investigator assessed the event as moderate in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.***additional information received on (b)(6) 2018 and (b)(6) 2018*** - on (b)(6) 2018, the patient experienced an adverse event of bladder infection.She was treated with ampicillin and the event has not resolved or recovered.-the patient presented urinary tract infection on (b)(6) 2015.She was treated with antibiotics and the event resolved on (b)(6) 2015.The investigator assessed the event as mild in severity, pelvic floor related, possibly related to the procedure, and possibly related to the study device.

Manufacturer Narrative

Blocks event updated.  patient code for infection ((b)(6)) has been added to capture the events of uti and bladder infection.The event of urinary tract infection with onset (b)(6) 2015 for this patient was previously reported under mfr report 3005099803-2015-03587.

• 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: 6544417
• MDR Text Key: 74422555
• Report Number: 3005099803-2017-01263
• Device Sequence Number: 1
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: (01)08714729774198(17)20171231(10)0001504063
• 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
• Report Date: 04/06/2017

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: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001504063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR