• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Adhesion(s) (1695); Scar Tissue (2060); Prolapse (2475); No Code Available (3191)
Event Date 07/31/2015
Event Type  Injury  
Manufacturer Narrative
(b)(6) (b)(4). (b)(6). The complainant indicated that the device is implanted and 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 was implanted during a pelvic floor reconstruction with xenform including cystocele repair procedure performed on (b)(6) 2015. The procedure was completed without complications. According to the complainant, the patient experienced sensation of bulge related to the posterior and apical vaginal compartments on (b)(6) 2015. A pessary was placed to treat the event on (b)(6) 2015 and (b)(6) 2015, and was subsequently removed on (b)(6) 2015 and (b)(6) 2015. On (b)(6) 2015, the patient underwent retreatment for prolapse including laparoscopic total hysterectomy, apical vault suspension, rectocele repair, and enterocele repair with xenform graft. During the procedure it was noted that there were severe left hemipelvic adhesions encompassing the left adnexal strictures including ovary and tube, creating significant scar tissue that the left ovary and tube were barely visible. The event resolved on (b)(6) 2015 and the patient was discharged on the same day. The event was assessed as probably related to the index procedure, and probably related to the study device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
TEI BIOSCIENCES INCORPORATED
7 elkins street
boston MA 02127
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key9112308
MDR Text Key161714482
Report Number3005099803-2019-04590
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
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 Number830-245
Device Lot Number0001404013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2019 Patient Sequence Number: 1
-
-