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

Model Number M0068302450

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

Patient Problems Edema (1820); Pain (1994); Swelling (2091); Disability (2371)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by the patient.(b)(4).The complaint device 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

It was reported to boston scientific corporation that a xenform tissue repair matrix was implanted into the patient during a prolapse procedure performed on (b)(6) 2016 for the treatment of prolapse.According to the patient, after the procedure, the patient has experienced large swelling/edema that is obvious in a large square shape around the patient's tailbone region/lower spine.Reportedly, the patient's tailbone would ache and sting after sitting for longer than 30 minutes.In addition, the patient is unable to lift more than 3kg again and is only able to sleep on back.Subsequently, the patient takes mersyndal forte or mersyndal capets to help with pain in the nighttime and is also on antidepressants, trialled lyrica for pain, and gabapentin and beta blockers plus mobic and somac to help with pain and swelling.The patient also regularly sees a clinical therapist since her prolapse surgery.Boston scientific has been unable to obtain additional information regarding the event to date.

• 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: 10900265
• MDR Text Key: 218245157
• Report Number: 3005099803-2020-05630
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 08714729773764
• UDI-Public: 08714729773764
• Combination Product (y/n): N
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068302450
• Device Catalogue Number: 830-245
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention