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

Model Number	10605
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break and stent inadequate apposition occured.The target lesion was located in the right coronary artery (rca).After an unknown stent was deployed in the proximal rca, it was decided to place another stent distally.A 4.00 x 28 synergy drug-eluting stent was advanced to the distal lesion.However, during inflation at 12 atmosphere, the stent delivery balloon started to deflate immediately.The stent was not fully deployed.When the stent delivery system was attempted to be removed, the shaft came out without the balloon.The physician attempted to retrieve the remaining balloon and stent for two hours, but as unsuccessful and the patient was sent to surgery for retrieval.No further patient complications were reported.

• 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: 8268913
• Report Number: 2134265-2019-00213
• Device Sequence Number: 1826278
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0021724008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2018
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention