MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that a shaft break occurred.A 4.50 x 24 synergy ii drug eluting stent (des) got kinked and broke outside the patient.The procedure was completed with a 4.0x24mm synergy ii des.There were no patient complications and the patient is fine.
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that a shaft break occurred.A 4.50 x 24 synergy ii drug eluting stent (des) got kinked and broke outside the patient.The procedure was completed with a 4.0x24mm synergy ii des.There were no patient complications and the patient is fine.It was further reported that the shaft broke 25-30 cm from the hub.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9282811
• Report Number: 2134265-2019-13437
• Device Sequence Number: 2524802
• Product Code: NIQ
• UDI-Device Identifier: 08714729973379
• UDI-Public: 08714729973379
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• 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): 12/13/2019

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: 06/16/2021
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0023989759
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1