MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number 10603

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.A 2.75 x 20 synergy ii drug-eluting stent was advanced for treatment.However, during removal, the stent struts were damaged.There were no patient complications nor injuries reported.

Event Description

It was reported that stent damage occurred.A 2.75 x 20 synergy ii drug-eluting stent was advanced for treatment.However, during removal, the stent struts were damaged.There were no patient complications nor injuries reported.It was further reported that the target lesion was 70% stenosed, moderately tortuous and moderately calcified.The procedure was completed with another of same device.The patient's status was stable.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11223112
• MDR Text Key: 228439861
• Report Number: 2134265-2021-00715
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0026257400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1