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); Urinary Retention (2119); Dysuria (2684)

Event Date 03/01/2015

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 with xenform including apical vault suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications and the patient was discharged on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient presented with new stress incontinence.The investigator assessed the event as moderate in severity, pelvic floor related and probably related to the study procedure but not related to the device.The subject was treated with physical therapy and prescribed vesicare and toviaz for the incontinence.On (b)(6) 2015, the subject presented with dysuria.The subject was prescribed cipro and the event resolved on (b)(6) 2015.The investigator assessed the event as moderate in severity, pelvic floor related and possibly related to the procedure but not 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 with xenform including apical vault suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications and the patient was discharged on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient presented with new stress incontinence.The investigator assessed the event as moderate in severity, pelvic floor related and probably related to the study procedure but not related to the device.The subject was treated with physical therapy and prescribed vesicare and toviaz for the incontinence.On (b)(6) 2015, the subject presented with dysuria.The subject was prescribed cipro and the event resolved on (b)(6) 2015.The investigator assessed the event as moderate in severity, pelvic floor related and possibly related to the procedure but not related to the device.Additional information received on june 17, 2015.The stress incontinence was experienced by the patient on (b)(6) 2014 and not (b)(6) 2014.It resolved on (b)(6) 2015.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications and the patient was discharged on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient presented with new stress incontinence.The investigator assessed the event as moderate in severity, pelvic floor related and probably related to the study procedure but not related to the device.The subject was treated with physical therapy and prescribed vesicare and toviaz for the incontinence.On (b)(6) 2015, the subject presented with dysuria.The subject was prescribed cipro and the event resolved on (b)(6) 2015.The investigator assessed the event as moderate in severity, pelvic floor related and possibly related to the procedure but not related to the device.Additional information received on may 8, 2015.On (b)(6) 2015, the patient experienced difficulty emptying her bladder.No treatment was given and the event was reported to be not yet resolved.Additional information received on june 17, 2015.The stress incontinence was experienced by the patient on (b)(6) 2014 and not (b)(6) 2014.It resolved on (b)(6) 2015.Additional information received on july 31, 2015.On (b)(6) 2015, the patient experienced yeast infection.She was treated with diflucan and the event is not yet resolved.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications and the patient was discharged on (b)(4) 2014.According to the complainant, on (b)(6) 2014, the patient presented with new stress incontinence.The investigator assessed the event as moderate in severity, pelvic floor related and probably related to the study procedure but not related to the device.The subject was treated with physical therapy and prescribed vesicare and toviaz for the incontinence.On (b)(6) 2015, the subject presented with dysuria.The subject was prescribed cipro and the event resolved on (b)(6) 2015.The investigator assessed the event as moderate in severity, pelvic floor related and possibly related to the procedure but not related to the device.Additional information received on may 8, 2015.On (b)(6) 2015, the patient experienced difficulty emptying her bladder.No treatment was given and the event was reported to be not yet resolved.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications and the patient was discharged on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient presented with new stress incontinence.The investigator assessed the event as moderate in severity, pelvic floor related and probably related to the study procedure but not related to the device.The subject was treated with physical therapy and prescribed vesicare and toviaz for the incontinence.On (b)(6) 2015, the subject presented with dysuria.The subject was prescribed cipro and the event resolved on (b)(6) 2015.The investigator assessed the event as moderate in severity, pelvic floor related and possibly related to the procedure but not related to the device.Additional information received on may 8, 2015.On (b)(6) 2015, the patient experienced difficulty emptying her bladder.No treatment was given and the event was reported to be not yet resolved.Additional information received on june 17, 2015.The stress incontinence was experienced by the patient on (b)(6) 2014 and not (b)(6) 2014.It resolved on (b)(6) 2015.Additional information received on july 31, 2015.On (b)(6) 2015, the patient experienced yeast infection.She was treated with diflucan and the event is not yet resolved.Additional information received on may 18, 2016.The subject underwent pelvic floor reconstruction surgery with xenform including sacrospinous ligament fixation and not apical vault suspension.The event of yeast infection resolved on (b)(6) 2015.

Event Description

It was reported to boston scientific corporation that a xenform tissue repair matrix was used during a pelvic floor repair procedure with xenform including apical vault suspension and cystocele repair performed on (b)(6) 2014.The procedure was completed without complications and the patient was discharged on (b)(6) 2014.According to the complainant, on (b)(6) 2014, the patient presented with new stress incontinence.The investigator assessed the event as moderate in severity, pelvic floor related and probably related to the study procedure but not related to the device.The subject was treated with physical therapy and prescribed vesicare and toviaz for the incontinence.On (b)(6) 2015, the subject presented with dysuria.The subject was prescribed cipro and the event resolved on (b)(6) 2015.The investigator assessed the event as moderate in severity, pelvic floor related and possibly related to the procedure but not related to the device.Additional information received on may 8, 2015: on (b)(6) 2015, the patient experienced difficulty emptying her bladder.No treatment was given and the event was reported to be not yet resolved.Additional information received on june 17, 2015: the stress incontinence was experienced by the patient on (b)(6) 2014 and not (b)(6) 2014.It resolved on (b)(6) 2015.Additional information received on july 31, 2015: on (b)(6) 2015, the patient experienced yeast infection.She was treated with diflucan and the event is not yet resolved.Additional information received on may 18, 2016: the subject underwent pelvic floor reconstruction surgery with xenform including sacrospinous ligament fixation and not apical vault suspension.The event of yeast infection resolved on (b)(6) 2015.Additional information received on september 21, 2018:- the events of (b)(6) 2014 stress incontinence and (b)(6) 2015 dysuria were reassessed as possibly related to the study device.

Manufacturer Narrative

Alternative patient id: (b)(6).

• 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
• MDR Report Key: 4541125
• MDR Text Key: 17293849
• Report Number: 3005099803-2015-00466
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/30/2015

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: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: M0068302470
• Device Lot Number: 0001403009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 09/21/2018
• Supplement Dates FDA Received: 06/02/2015; 07/08/2015; 06/09/2016; 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 79