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

Model Number	10603
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter removal difficulty and shaft break occurred.A 3.50 x 20 synergy drug-eluting stent was selected for treatment.During advancement, mild resistance was encountered and the proximal shaft of the catheter bent or kinked to about 30 degrees near the hemostatic valve.The stent was into the guide catheter by about one-third to one-half of its length.The physician decided to remove the stent.The bent area straightened during withdrawal, but there was resistance through the hemostatic valve.The catheter shaft broke at this time.The device was in the patient's body and the other half of the catheter was pulled out with hemostats.The procedure was completed with a non-bsc stent.No complications were reported and the patient was not harmed.
Event or Problem Description
It was reported that removal difficulty and shaft break occurred.A 3.50 x 20 synergy drug-eluting stent was selected for treatment.However, during advancement, the proximal shaft of the catheter bent or kinked to about 30 degrees near the hemostatic valve.The stent was into the guide catheter by about one-third to one-half of its length.The physician decided to remove the stent.The bent area straightened during withdrawal but there was resistance through the hemostatic valve.The catheter shaft broke at this time.The device was in the patient's body and the other half of the catheter was pulled out with hemostats.The procedure was completed with a non-bsc stent.No complications were reported and the patient was not harmed.

• 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: 10515123
• Report Number: 2134265-2020-11570
• Device Sequence Number: 11373888
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: 08714729840183
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/13/2020

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: 11/25/2020
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023025959
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR