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 Code	Insufficient Information (4580)
Date of Event	02/06/2014
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) 2014, 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: (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
It was reported to boston scientific corporation that a xenform graft device was implanted into the patient during a robotic-assisted laparoscopic sacrocolpopexy, lysis of adhesions, excision of exposed mesh intraabdominally, repair of immediately recognized rectal injury, peritoneal flap advancement as an interposing flap, and placement of a biologic interposing graft for the treatment of recurrent enterocele and rectocele status post-history of transvaginal surgical procedure to correct prolapse and mesh exposure with adherence to small bowel intraabdominally procedures on (b)(6) 2014.Prior to placement of the xenform, during posterior dissection for the placement of a non-bsc y-mesh, the rectal wall reportedly had a small opening during the dissection process that was detected right away and measured less than 2 cm.A two-layer closure was then decided to perform.A xenform was placed to interpose between the anticipated placement of the non-bsc y-mesh and the repair of the rectal defect.The patient tolerated the procedure well; consequently, she 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: 16850577
• Report Number: 3005099803-2023-02180
• Device Sequence Number: 15146400
• Product Code: FTM
• UDI-Device Identifier: 08714729774198
• UDI-Public: 08714729774198
• 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: 2014
• 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): 05/01/2023

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: 05/31/2014
• Device Model Number: M0068302470
• Device Catalogue Number: 830-247
• Device Lot Number: 0001111007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• 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: 68 YR
• Patient Sex: Female