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

Model Number	10605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left main(lm)/left anterior descending artery.This was a transcatheter aortic valve replacement (tavr) case, however the lm was known to have low origin in root.In efforts to protect lm, 6f fl4, 6f guidezilla, a non-bsc guidewire and a 4.0 x 28 synergy drug-eluting stent (undeployed) were placed in lm before a transcatheter aortic valve deployment.The stent was still loaded on balloon and was never attempted to be deployed.The stent stripped off the balloon and in between the aortic root and the tavr valve at 6-8mm into the lm.The lm was wired with a separate guide catheter, guidewire and the 4.0 x 12mm synergy stent was deployed.Post-dilatation was performed with a 5.5mm nc balloon catheter.The 4.0 x 12 synergy stent was deployed to crush the 4.0 x 28 synergy stent against the artery wall and the procedure was completed.No 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: 10646693
• Report Number: 2134265-2020-13139
• Device Sequence Number: 14366560
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: 10/06/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024594407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/07/2020
• 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