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

Model Number	10605
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Used (b)(6) 2019 as event date since the correct date was not provided.
Event or Problem Description
It was reported that removal difficulties were encountered.A 2.50mm x 28mm and 3.5mmx38mm synergy drug-eluting stents were deployed in the target lesion.However, post-deployment, the delivery balloons were stuck in the deployed stents and it took a lot of force to remove them.Upon inspection, it was noticed that the balloon seemed to wad up at the distal end of the shafts.The procedure was completed.No patient complications were reported and the patient was not harmed.

• 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: 8687916
• Report Number: 2134265-2019-06293
• Device Sequence Number: 19590476
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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: 08/14/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022551532
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1