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 Prolapse (2475)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The complainant indicated that the device 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 soft tissue repair matrix device was implanted in the patient on (b)(6) 2015 during a pelvic floor repair procedure.According to the complainant, on (b)(6) 2016, the patient experienced posterior prolapse.No treatment has been given and the event has not yet resolved.

Event Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix device was implanted in the patient on (b)(6) 2015 during a pelvic floor repair procedure.According to the complainant, on (b)(6) 2016, the patient experienced posterior prolapse.No treatment has been given and the event has not yet resolved.Additional information received on october 16, 2017.On (b)(6) 2017, the patient again experienced prolapse.On (b)(6) 2017, the subject underwent pelvic floor reconstruction with xenform including bilateral sacrospinous ligament suspension, enterocele repair and rectocele repair and the event resolved on (b)(6) 2017.

• 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: 5575245
• MDR Text Key: 42606234
• Report Number: 3005099803-2016-01053
• Device Sequence Number: 1
• Product Code: PAJ
• 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,Followup
• Report Date: 03/18/2016

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: 12/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001504063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2015
• 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): Other
• Patient Age: 65 YR
• Patient Weight: 65