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 Erosion (1750); Pain (1994)

Event Date 04/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix device was implanted during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2015, the patient experienced a suture exposure in the anterior vagina with associated spontaneous pain.The suture exposure and the pain resolved on (b)(6) 2015 by cauterizing the granulation tissue with silver nitrate and trimming the suture.

Manufacturer Narrative

Additional/alternative patient identifier: (b)(6).The event reported in this report ¿suture exposure in the anterior vagina associated with spontaneous pain¿ with onset (b)(6) 2015 for this patient was also reported previously under mfr report #3005099803-2015-01182.Any further information regarding the event will be sent under mfr report 3005099803-2015-01182.

Event Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix device was implanted during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2015, the patient experienced a suture exposure in the anterior vagina with associated spontaneous pain.The suture exposure and the pain resolved on (b)(6) 2015 by cauterizing the granulation tissue with silver nitrate and trimming the suture.

• 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: 6892844
• MDR Text Key: 87295975
• Report Number: 3005099803-2017-02845
• Device Sequence Number: 1
• Product Code: PAJ
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• 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: 09/05/2017

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: 01/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001403009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/25/2017
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2014
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 78