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

Model Number	10603
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: above 18 years and older.Device is a combination product.
Event or Problem Description
It was reported that stent damaged post-deployment occurred and the stent was explanted.The target lesion was located in a vein graft to obtuse marginal branch segment.A 190 cm filterwire was advanced and situated in the lesion.Then, a 3.50 x 20mm synergy ii drug-eluting stent was deployed in the ostium for treatment.However, when the filterwire was attempted to be retrieved, the retrieval device would not go through the deployed stent.A non-bsc guide wire was advanced as a buddy wire and was tried to remove the retrieval device.When the buddy wire and filterwire were removed, the deployed stent was physically pulled out and mangled.The procedure was completed with a 3.5 x 24mm synergy ii drug-eluting stent.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: 8735699
• Report Number: 2134265-2019-07375
• Device Sequence Number: 19492268
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: 08714729840183
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023651500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1