MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM; 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); Prolapse (2475); No Code Available (3191)

Event Date 03/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the patient had recurrent cystocele and recurrent vaginal vault prolapse.She was implanted with a xenform device during a procedure for sacrospinous ligament fixation, with concomitant revision of a previously-implanted non-bsc mesh device.As reported by the patient's attorney, on (b)(6) 2015, the patient underwent a procedure for cystocele repair with native tissue due to recurrent cystocele, recurrent infections, and incomplete bladder emptying.Boston scientific has been unable to obtain additional information regarding the event to date.

• Brand Name: XENFORM
• Type of Device: MESH, 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): INTEGRA LIFE SCIENCES SALES LLC; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9834501
• MDR Text Key: 186615777
• Report Number: 3005099803-2020-01042
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2020

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: 09/30/2016
• Device Model Number: M0068302470
• Device Catalogue Number: 830-247
• Device Lot Number: 0001404014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR