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

Model Number	10603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 since there was no date provided.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 20 synergy ii drug-eluting stent was advanced for treatment.However, during insertion, the device broke and was unable to cross the lesion.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 20 synergy ii drug-eluting stent was advanced for treatment.However, during insertion, the device broke and was unable to cross the lesion.No patient complciations were reported.It was further reported the target lesion was 80% stenosed and was moderately tortuous and moderately calcified.The break occurred approximately 40cm from the hub.The device was completely removed and the procedure was completed with a non-bsc device.
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2020 since there was no date provided.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: 10144066
• Report Number: 2134265-2020-06936
• Device Sequence Number: 3053355
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/25/2020

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: 08/06/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024271367
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1