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

Model Number	10604
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that the stent was explanted.The target lesion was located in the left anterior descending artery.A 2.50 x 24mm synergy drug-eluting stent was implanted for treatment.However, a non-bsc guide wire became entangled with the newly placed stent and when trying to retract the wire, the stent dislodged from the coronary artery and stayed on the wire until the wire was retracted to the femoral artery.The physician was able to retrieve the deployed stent out with a snare.No further patient complications were reported.
Event or Problem Description
It was reported that the stent was explanted.The target lesion was located in the left anterior descending artery.A 2.50 x 24mm synergy drug-eluting stent was implanted for treatment.However, a non-bsc guide wire became entangled with the newly placed stent and when trying to retract the wire, the stent dislodged from the coronary artery and stayed on the wire until the wire was retracted to the femoral artery.The physician was able to retrieve the deployed stent out with a snare.No further patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 24mm stent was returned for analysis.The stent was noted to be expanded and damaged.The stent delivery system was not reurned for analysis.

• 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: 10214451
• Report Number: 2134265-2020-07987
• Device Sequence Number: 2133923
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 08/12/2020

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: 02/02/2022
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0025215885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: BMW; GUIDEWIRE: BMW; GUIDEWIRE: BMW
• Outcome Attributed to Adverse Event: Required Intervention