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 Edema (1820); Pain (1994); Urinary Retention (2119)

Event Date 01/12/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2015, the patient experienced urinary retention.The patient was taught to self-catheterize and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, not related to the procedure, and probably related to the device.On (b)(6) 2015, the patient also experienced edemetous urethral.The patient was unable to self-catheterize, so a foley catheter was placed and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, possibly related to the procedure, and possibly related to the device.On (b)(6) 2015, the patient also experienced pelvic pain.The patient was treated with valium and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, possibly related to the procedure, and possibly related to the device.

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 tissue repair matrix was used during a pelvic floor repair procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2015, the patient experienced urinary retention.The patient was taught to self-catheterize and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, not related to the procedure, and probably related to the device.On (b)(6) 2015, the patient also experienced edematous urethral.The patient was unable to self-catheterize so a foley catheter was placed and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, possibly related to the procedure, and possibly related to the device.On (b)(6) 2015, the patient also experienced pelvic pain.The patient was treated with valium and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, possibly related to the procedure, and possibly related to the device.Additional information received on may 26 and 29, 2015.Edematous urethral and pelvic pain resolved on (b)(6) 2015.The urinary retention resolved on (b)(6) 2015.Additional information received on august 12, 2015.The event of urinary retention experienced on (b)(6) 2015 as initially reported.The event of pelvic pain experienced by patient on (b)(6) 2015 as initially reported.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2015, the patient experienced urinary retention.The patient was taught to self-catheterize and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, not related to the procedure, and probably related to the device.On (b)(6) 2015, the patient also experienced edematous urethral.The patient was unable to self-catheterize so a foley catheter was placed and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, possibly related to the procedure, and possibly related to the device.On (b)(6) 2015, the patient also experienced pelvic pain.The patient was treated with valium and the event has not yet resolved.The investigator assessed the event as moderate in severity, not pelvic floor related, possibly related to the procedure, and possibly related to the device.Additional information received on may 26 and 29, 2015.Edematous urethral and pelvic pain resolved on (b)(6) 2015.The urinary retention 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: 4494044
• MDR Text Key: 5563923
• Report Number: 3005099803-2015-00327
• 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: 01/14/2015

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: 08/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001409032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2014
• 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: 48 YR
• Patient Weight: 75