MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10617
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter removal difficulty was encountered and stent migration occurred.The target lesion was located in the left main (lm) artery.A 5.00 x 12 synergy drug-eluting stent was deployed for treatment.However, when balloon was deflated it was not able to be retracted into the guide catheter.The balloon became stuck in the distal end/opening of the guide catheter.The entire guide catheter was then removed and a new one was inserted.It was then noted that the deployed stent was no longer in the lm and was found to be in the iliac artery upon computerized tomography (ct) imaging.The patient was okay and no further patient complications were reported.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10815770
• Report Number: 2134265-2020-15362
• Device Sequence Number: 2113915
• Product Code: NIQ
• UDI-Device Identifier: 08714729973423
• UDI-Public: 08714729973423
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• 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): 11/10/2020

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: 11/05/2021
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0024769494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention