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

Model Number	10604
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the calcified left main artery.A 4.00 x 24 synergy drug-eluting stent was advanced for treatment.However, it was noted that the distal edge of the stent strut flared out.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the calcified left main artery.A 4.00 x 24 synergy drug eluting stent was advanced for treatment.However, it was noted that the distal edge of the stent strut flared out.The device was removed and the procedure was completed with another of the same device.No patient complication were reported and the patient was fine.It was further reported that the target lesion was 90% stenosed, moderately tortuous and severely calcified.The lesion was pre-dilated and significant resistance was encountered when advancing the device.
Additional Manufacturer Narrative
Device is a combination product.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9836718
• Report Number: 2134265-2020-03370
• Device Sequence Number: 1299719
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024177119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR