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); Swelling (2091)

Event Date 08/25/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a cystocele and rectocele repairs procedure performed on august 13, 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2014 the patient experience exposure in the vagina.The exposure was <1cm in size and occurred in the area of the vaginal suture line.This was assessed by the investigator as related to the pelvic floor, the study device and the procedure.On (b)(6) 2014, the patient experienced pelvic pain-vulvar and perineal swelling due to the small exposure of the xenform graft.The investigator assessed the event as pelvic floor related and possibly related to the index procedure and to the device.The event resolved on (b)(6) 2014.

Manufacturer Narrative

The complainant indicated that the device was implant 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 cystocele and rectocele repairs procedure performed on (b)(6) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2014 the patient experience exposure in the vagina.The exposure was <1cm in size and occurred in the area of the vaginal suture line.This was assessed by the investigator as related to the pelvic floor, the study device and the procedure.On (b)(6) 2014, the patient experienced pelvic pain-vulvar and perineal swelling due to the small exposure of the xenform graft.The investigator assessed the event as pelvic floor related and possibly related to the index procedure and to the device.The event resolved on (b)(6) 2014.Correction and additional information march 12, 2015.The mesh exposure resolved without treatment on (b)(6) 2014.However, for the pelvic pain with vulvar and perineal swelling, topical 2% lidocaine was given to treat the discomfort and the event resolved on an unknown date.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a cystocele and rectocele repairs procedure performed on (b)(6) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2014 the patient experience exposure in the vagina.The exposure was <1cm in size and occurred in the area of the vaginal suture line.This was assessed by the investigator as related to the pelvic floor, the study device and the procedure.On (b)(6) 2014, the patient experienced pelvic pain-vulvar and perineal swelling due to the small exposure of the xenform graft.The investigator assessed the event as pelvic floor related and possibly related to the index procedure and to the device.The event resolved on (b)(6) 2014.Correction and additional information march 12, 2015.The mesh exposure resolved without treatment on (b)(6) 2014.However, for the pelvic pain with vulvar and perineal swelling, topical 2% lidocaine was given to treat the discomfort and the event resolved on an unknown date.Additional information july 2, 2015.The event of pelvic pain with vulvar and perineal swelling resolved on (b)(6) 2015.

• 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: 4218398
• MDR Text Key: 5078287
• Report Number: 3005099803-2014-03449
• 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: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2014

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: 05/31/2016
• Device Model Number: M0068302470
• Device Lot Number: 0001308016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 10/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/07/2015; 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2013
• 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: 46 YR
• Patient Weight: 60