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

Model Number M0068302430

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Scar Tissue (2060); Urinary Retention (2119); Obstruction/Occlusion (2422)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

This event was reported by the patient's legal representation.The implanting and sling removal surgeon is: dr.(b)(6), hospital ambulatory surgery.(b)(4).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

Note: this manufacturer report pertains to the third of three devices implanted during the same procedure.It was reported to boston scientific corporation that the patient was diagnosed with lateral cystocele, post hysterectomy vaginal vault prolapse, enterocele, rectocele, urodynamic stress urinary incontinence, weak rectovaginal tissue and ovarian adhesions.On (b)(6) 2017, the patient was implanted with upsylon y-mesh, advantage fit system and xenform devices during a bilateral salpingo-oophorectomy, sacrocolpopexy, enterocele repair, bilateral paravaginal repair, tension-free vaginal tape, urethroscopy, rectocele repair, anal sphincteroplasty, placement of xeno graft due to weak and, friable pelvic floor tissue, lysis of adhesions (loa), vaginal packing due to extensive dissection and oozing and foley placement procedure.On (b)(6) 2018, the patient underwent removal of stress urinary incontinence sling (advantage), urethrolysis and urethrocystoscopy procedure due to irritative obstructive symptoms with urinary retention.During urethrolysis, the physician removed the scar tissue surrounding the urethra and mobilized the urethra through lysis of adhesions to free it up completely.Urethra was then dilated to 10 f dilator.There was no pain or dyspareunia related to the sling.During the revision surgery, it was noted that there was no urethral blockage on the urethra, no abnormality of urethra, bladder neck or trigone, no erosion of the sling material into the urethra or the bladder, and no tumors, stones, foreign bodies or chronic inflammation to explain the patient's urgency.The sling was found to be in mid-urethra and exerting normal tension on the urethra.Urine was effluxing from either ureter without any difficulty in good jet fashion.The patient was reported to be in stable condition after the procedure.There was no apparent untoward event reported.

• 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): TEI BIOSCIENCES INCORPORATED; 7 elkins street; boston MA 02127
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11408953
• MDR Text Key: 234613585
• Report Number: 3005099803-2021-00799
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 08714729774464
• UDI-Public: 08714729774464
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: M0068302430
• Device Catalogue Number: 830-243
• Device Lot Number: 0001705002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR