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

Model Number	10604
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Code Available (3191)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that vessel dissection occurred and the patient was sent for surgery.The patient was presented with significant disease in the distal segment of a dominate target lesion located in the moderately calcified left circumflex artery.The physician used a non bsc guidewire and pre-dilated the lesion.A 3.50 x 24 synergy drug-eluting stent was advanced with a little difficulty but was successfully deployed.Upon deflation of the stent delivery system, the balloon would not release from the stent.Repeated inflation and deflations of the stent delivery balloon were attempted without success.The physician used a 20cc syringe and attached it to the stent hub and aspirated and then took a non bsc guidewire to wired through the stent and next to the trapped balloon.However, it was unable to advance a small balloon through the stent.More force was performed to remove the balloon.But, during this attempt the guide catheter advanced into the left main and caused a dissection.The stent delivery shaft also broke at a point just proximal to the balloon.The decision was made to send the patient for surgery.The patient did well, no further complications were reported and is currently recovering.

• 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: 8352052
• Report Number: 2134265-2019-01413
• Device Sequence Number: 14024620
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: 08714729840244
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/19/2019

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: 06/25/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 22337195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/19/2019
• 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
• Patient Age: 72 YR