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 UNK166

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a xenform device was used during a pelvic floor reconstruction with native tissue procedure performed on (b)(6) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2014 the patient experienced a pelvic infection/abscess with associated pelvic pain.The event was reported as a serious adverse event that resulted in in-patient hospitalization and medical/surgical intervention.The subject was admitted to the hospital and to the icu/ccu on (b)(6) 2014.The type of intervention was not yet specified by the site.

Manufacturer Narrative

The complainant indicated that the device was 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 device was used during a pelvic floor reconstruction with native tissue procedure performed on (b)(6) 2014.The procedure was completed without complications.According to the complainant, on (b)(6) 2014 the patient experienced a pelvic infection/abscess with associated pelvic pain.The event was reported as a serious adverse event that resulted in in-patient hospitalization and medical/surgical intervention.The subject was admitted to the hospital and to the icu/ccu on (b)(6) 2014.The type of intervention was not yet specified by the site.Correction: the patient was not implanted with a xenform device.The patient was part of the xenform study, but was in the native tissue repair arm.

• 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: 4150753
• MDR Text Key: 4926700
• Report Number: 3005099803-2014-03321
• 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,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2014

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 Model Number: UNK166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 65