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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

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BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO Back to Search Results
Model Number M0068302450
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Discomfort (2330); Obstruction/Occlusion (2422); Constipation (3274)
Event Date 03/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). (b)(4). Study name: (b)(6). The complaint device is not expected to 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 implanted during a pelvic floor repair procedure with xenform including vaginal-approach hysteropexy procedure performed on (b)(6) 2016. According to the complainant, on (b)(6) 2016, the patient presented with bladder outlet obstruction and was admitted to the hospital on (b)(6) 2016. She underwent a revision prolapse surgery and the device was completely removed from the posterior vaginal wall. She was then discharged on (b)(6) 2016 and the event of obstruction resolved on (b)(6) 2016.
 
Event Description
It was reported to boston scientific corporation that a xenform device was implanted during a pelvic floor repair procedure with xenform including vaginal-approach hysteropexy procedure performed on (b)(6) 2016. According to the complainant, on (b)(6) 2016, the patient presented with bladder outlet obstruction and was admitted to the hospital on (b)(6) 2016. She underwent a revision prolapse surgery and the device was completely removed from the posterior vaginal wall. She was then discharged on (b)(6) 2016 and the event of obstruction resolved on (b)(6) 2016. Additional information received on november 30, 2018. On (b)(6) 2016, aside from bladder outlet obstruction, the patient also experienced fecal impaction, wound infection in the posterior compartment with symptoms of difficulty voiding, increased vaginal pain, malaise, and vaginal drainage. The patient reportedly had tried multiple stool softeners and enemas and was able to have a bowel movement. On (b)(6) 2016, the patient was admitted to the hospital and underwent an inpatient surgical intervention including transurethral mobilization of sling, and complete explant of the study device from the posterior vaginal wall. The patient was then discharged from the hospital on (b)(6) 2016. She was also treated with iv antibiotics for the wound infection. All events were resolved on (b)(6) 2016. The investigator assessed the wound infection and fecal impaction events as moderate in severity and pelvic floor related. The assessment of the relationship of this to the procedure and/or device has not yet been provided.
 
Manufacturer Narrative
Patient id: (b)(6). Study name: (b)(4).
 
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Brand NameXENFORM
Type of DeviceMESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7846961
MDR Text Key119324936
Report Number3005099803-2018-60282
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K060984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2016
Device Model NumberM0068302450
Device Catalogue Number72920
Device Lot Number0001404013
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
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