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

Model Number 10604

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event 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and when trying to retract the wire, the stent dislodged from the coronary artery and stayed on the wire until the wire was retracted to the femoral artery.The physician was able to retrieve the deployed stent out with a snare.No further patient complications were reported.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 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and when trying to retract the wire, the stent dislodged from the coronary artery and stayed on the wire until the wire was retracted to the femoral artery.The physician was able to retrieve the deployed stent out with a snare.No further patient complications were reported.

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
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10214451
• MDR Text Key: 197013813
• Report Number: 2134265-2020-07987
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: BMW; GUIDEWIRE: BMW; GUIDEWIRE: BMW
• Patient Outcome(s): Required Intervention