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

Model Number	10601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the aorta.A 2.50mmx12mm synergy drug-eluting stent was selected for use.However, upon loading the device onto the wire, the shaft broke inside the guide.The device was completely removed together with the guide.The procedure was completed by replacing with a new guide catheter, guide wire and a different stent.No patient complications were reported and the patient was okay.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by manufacturer.: synergy ii us mr 2.50 x 12 mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube found multiple hypotube kinks and a break 864mm distal to the distal end of the strain relief.Section of the device distal of the break site (including distal section of hypotube, mid-shaft, shaft polymer extrusion, balloon, stent and tip) was not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the aorta.A 2.50mm x 12mm synergy drug-eluting stent was selected for use.However, upon loading the device onto the wire, the shaft broke inside the guide.The device was completely removed together with the guide.The procedure was completed by replacing with a new guide catheter, guide wire and a different stent.No patient complications were reported and the patient was okay.

• 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: 8387006
• Report Number: 2134265-2019-01885
• Device Sequence Number: 2326457
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/07/2019

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: 10/10/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 22809491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR