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

Model Number	10607
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The patient presented with non-st elevation myocardial infarction.Vascular access was obtained via the left common femoral artery.The target lesion was located in the heavily calcified and very tortuous right coronary artery.Following pre-dilatation from the distal to proximal rca and within the previously implanted stent using a 2.75 x 20mm balloon, a 3.00 x 38mm synergy ii drug-eluting stent was advanced but failed to cross the lesion due to the calcification and tortuosity.The stent was pulled back into the guide catheter but was deformed and dislodged.The stent was held on by a wire within the aorta.It was successfully snared and the procedure was completed using a guide extension catheter and three non-boston scientific stents.No further patient complications were reported and the patient status was good.

• 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: 10751694
• Report Number: 2134265-2020-14847
• Device Sequence Number: 3773533
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 11/18/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024839229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: GUIDE CATHETER : 6-F JR; GUIDEWIRE: BMW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR