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

Model Number	M0068302450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2013 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).(b)(6 )hospital.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2401 unspecified personal injury.The following imdrf impact code capture the reportable event of: f12 patient had sought for a legal recourse for injuries related to the device.
Event or Problem Description
Note: this manufacturer report pertains to the third of three devices used during the same procedure.Please refer to mfr report 3005099803-2023-01849 and 3005099803-2023-01850 for the associated devices.It was reported to boston scientific corporation that a solyx sis system and xenform graft devices were implanted into the patient during a mid-urethral sling operation for stress incontinence, anterior and posterior colporrhaphy with repair of enterocele, insertion of a graft, vaginal colpopexy, hysteroscopy with polypectomy, and dilatation and curettage procedures performed on (b)(6) 2013, for the treatment of pelvic organ prolapse, cystocele, rectocele, enterocele, and endometrial polyps, and genuine stress urinary incontinence.The patient had third-degree prolapse of her uterus, bladder, and rectum, as well as a third-degree posterior defect that was a combined rectocele and enterocele, which were discovered during the procedure.She had a 2 cm polyp that was arising from the anterior uterine wall and appeared to be benign.Her uterus had prolapsed past the hymenal ring.Furthermore, no patient complications were reported during the procedure.The procedure was well tolerated by the patient, who was transferred to the recovery room in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury as a result of the surgery.

• 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: 16755939
• Report Number: 3005099803-2023-01854
• Device Sequence Number: 18299376
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 04/17/2023

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: 09/30/2014
• Device Model Number: M0068302450
• Device Catalogue Number: 830-245
• Device Lot Number: 0001301010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Race: White