MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number M0068318200

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

Patient Problems Fever (1858); Muscle Weakness (1967); Pain (1994); Osteomyelitis (4533)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021, the date bsc became aware of the event, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was used during an rscp (robotic sacrocolpopexy) procedure.According to the complainant, the patient had osteomyelitis infection during the procedure.Reportedly, the patient was doing okay managing with at home antibiotics.

Event Description

Note: this manufacturer report pertains to one of six devices implanted into different patients during different procedures.It was reported to boston scientific corporation that six patients were implanted with an upsylon y-mesh during rscp (robotic sacrocolpopexy) and laparoscopic sacrocolpopexy procedures performed separately between (b)(6) 2020 and (b)(6) 2020.After the implant procedure, symptoms developed two weeks post-operative follow-up or sooner.One patient presented to the er prior to two weeks post-operative follow-up with severe back pain, weakness, and fever.She was then diagnosed with sacral osteomyelitis and had a port placed to receive iv antibiotics for six weeks; two patients developed pain and fever and treated with oral antibiotics; and three patients with unknown symptoms also treated with oral antibiotics.Reportedly, the patients were doing okay managing with at home antibiotics.It is unknown which of the mentioned symptoms this patient has experienced and boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2021, the date bsc became aware of the event, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block e1: dr.(b)(6) used robotic approach during the procedure.Block h6: patient code e1628 captures the reportable event of osteomyelitis.Block h10: the complainant indicated that the device is implanted and 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.

• Brand Name: UPSYLON
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11320921
• MDR Text Key: 231582488
• Report Number: 3005099803-2021-00423
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: 08714729839217
• Combination Product (y/n): N
• PMA/PMN Number: K122794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention