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); Pain (1994); Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The exact age of the patient is unknown, however, it was reported the patient was over 18 years.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that the patient was implanted with a xenform soft tissue repair matrix device during a cystocele repair procedure on (b)(6) 2016.According to the complainant, after the procedure, the patient experienced urinary retention and her white blood count was at 24,000.On an unknown date, the physician noticed an abscess on her vaginal area where the graft was.Consequently, the abscess was drained and the graft was explanted.The patient was reported to have improved and was discharged on (b)(6) 2016.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Event Description

It was reported to boston scientific corporation that the patient was implanted with a xenform soft tissue repair matrix device during a cystocele repair procedure on (b)(6) 2016.According to the complainant, after the procedure, the patient experienced urinary retention and her white blood count was at 24,000 mcl.On an unknown date, the physician noticed an abscess on her vaginal area where the graft was.Consequently, the abscess was drained and the graft was explanted.The patient was reported to have improved and was discharged on (b)(6) 2016.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on february 22, 2016.On the same day after the operation, the patient was found out to have an infection which was manifested by fever aside from the increased white blood cells count.Also, the patient experienced lower abdominal/pelvic pain.The day after the procedure, the patient experienced urinary retention.On (b)(6) 2016, the graft was explanted and vaginal abscess was noticed.Subsequently, the patient was on antibiotics therapy (oral and intravenous) for two weeks.

• 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: 5413666
• MDR Text Key: 37569066
• Report Number: 3005099803-2016-00178
• 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: 01/13/2016

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: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: M0068302470
• Device Lot Number: 0001508026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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): Required Intervention