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

Model Number	10601
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered and patient had to undergo surgery.The target lesion was located in the calcified diagonal artery.A 2.50 x 12 synergy stent was advanced and successfully deployed.However, upon removal, there was difficulty in withdrawing the stent delivery system (sds).Several attempts were made to remove the sds, but physician stated that the balloon was stuck in the calcium and the stent.The balloon catheter was eventually removed; however, the balloon material was missing.The balloon was retained in the diag and a coronary artery bypass graft had to be performed.No further patient complications were reported.The patient left the procedure with a balloon pump in place, but otherwise stable.

• 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: 8166767
• Report Number: 2134265-2018-64115
• Device Sequence Number: 2792472
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/14/2018

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: 05/15/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022166209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/14/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 109