MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

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

Patient Problems Erosion (1750); Inflammation (1932); Pain (1994); Therapeutic Effects, Unexpected (2099); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371); No Code Available (3191)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6) hospital, (b)(6) by dr.(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

Note: this report pertains to first of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and an advantage fit system devices were implanted on (b)(6) 2017.As reported by the patient's attorney, the patient experienced severe and permanent injuries from the mesh products which include erosion and degradation of the mesh, causing chronic and recurrent inflammation, requiring surgical intervention to explant the mesh products.The mesh embedded in the patient's tissue over time requiring surgical removal due to its various defects, and such removal caused damage to organs and tissues, adversely affecting patient's health including physical impairment and disfigurement, chronic severe pain which is unrelieved by analgesic medication, and constant pulling sensations across the pelvic area.Furthermore, the device reportedly failed to perform the purpose of its implantation such that the patient required surgical removal of the products and repeated treatment and surgery.

• Brand Name: UPSYLON Y MESH KIT
• Type of Device: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL; coilleach; spiddal, co galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8791936
• MDR Text Key: 151086557
• Report Number: 3005099803-2019-03477
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• 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