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

Model Number	M0068302430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2015
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) 2015, 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).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 filed a legal claim for injuries related to the device.
Event or Problem Description
Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to mfr report 3005099803-2023-02693 for the associated device.It was reported to boston scientific corporation that an upyslon y-mesh and xenform graft device were implanted into the patient during a sacrocolpopexy-davinci-shd, extensive laparoscopic lysis of adhesions, right ureterolysis, exploratory laparotomy, cystotomy repair, and xenform graft placement procedure performed on (b)(6) 2015, for the treatment of vaginal prolapse, stress urinary incontinence, and dyspareunia.Extensive adhesions of the sigmoid, colon, and small bowel to the bladder and pelvic sidewalls were noted during surgery.A cystotomy was observed in the supratrigonal region that was repaired, as well as brisk outflow of clear urine from both ureters.There were no complications throughout the procedure.Furthermore, the patient tolerated the procedure well and was transferred to the recovery room in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.

• 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: 17015200
• Report Number: 3005099803-2023-02694
• Device Sequence Number: 7032199
• Product Code: FTM
• UDI-Device Identifier: 08714729774464
• UDI-Public: 08714729774464
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/26/2023

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: 07/31/2017
• Device Model Number: M0068302430
• Device Catalogue Number: 830-243
• Device Lot Number: 0001409012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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: 50 YR
• Patient Sex: Female