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

Model Number	M0068302470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Urinary Retention (2119)
Date of Event	12/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2015 was chosen as a best estimate based on the date of mesh removal surgery.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6) genesis healthcare system.Imdrf patient codes e1309 and e1715 capture the reportable events of urinary retention and scar tissue.Imdrf impact code f19 captures the reportable event of sling removal surgery.
Event or Problem Description
Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an advantage fit system and xenform devices were implanted into the patient during an anterior colporrhaphy, bilateral ss vaginal vault suspension/uterine suspension, rectocele repair, sling revision, tension free vaginal tape suburethral sling with bs system, placement of xeno graft, anal sphincteroplasty, bartholin cystectomy, skin biopsy, vaginal packing due to extensive dissection and oozing.Urethral cystoscopy, foley placement procedure performed on (b)(6) 2015 to treat midline cystocele, uterine prolapse, rectocele, urodynamic stress urinary incontinence, urinary frequency and urgency, fecal incontinence, weakened pelvic tissue.On (b)(6) 2015, the patient had revision of sling, urethrolysis and urethrocystoscopy due to irritative obstructive symptoms with urinary retention.Postoperative diagnose reported no obvious urethral blockage from the sling.The sling appeared to be in distal urethral portion of urethra.During the procedure, the sling was completely freed off from its attachment to the urethra and surrounding scar tissue was mobilized.The patient was transferred to the recovery room in stable condition.

• Brand Name: XENFORM
• Common Device Name: 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: 16384653
• Report Number: 3005099803-2023-00514
• Device Sequence Number: 5592593
• Product Code: FTM
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: M0068302470
• Device Catalogue Number: 72920
• Device Lot Number: 0001407014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female