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

Model Number	10607
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was damaged post-deployment, fractured, and left unretrieved device fragments requiring additional intervention.The target lesion was located in the distal left anterior descending artery (lad).A 2.25x38mm synergy ii drug-eluting stent was deployed in the lad over a non-bsc guidewire.A 3x20mm synergy was then inserted over the same non-bsc guidewire in the lad but failed to cross through the deployed stent.The 3x20mm undeployed stent was removed and a 3x15 emerge balloon was then advanced for stent post dilation.Another non-bsc guidewire was passed down the lad through the deployed stent as a buddy wire.Another attempt to cross through the previous deployed stent with the 3x20mm synergy stent once again failed.The two non-bsc guidewires were then removed with resistance and found to be damaged.Also, a part of the deployed stent was entangled in them.The stent had fractured and some of the stent remained behind in the lad.A new non-bsc guidewire was then inserted through the deployed stent and a 2.5x30mm non-bsc balloon was used for dilation in the lesion/stent area, then a 2x30mm emerge balloon was used.Two non-bsc stents were then deployed in the distal lad, crushing the remaining stent.Post-procedure echocardiogram was negative and the patient was transferred from cath lab pain free.

• 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: 10653281
• Report Number: 2134265-2020-13456
• Device Sequence Number: 4283594
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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: 01/20/2022
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0025142030
• 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: 10/08/2020
• 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