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

Model Number	10600
Medical Device Problem Codes	Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent inadequate apposition and stent migration occurred.The 69% stenosed target lesion with a 5.5-5.6mm vessel diameter was located in the left main coronary artery (lmca).Following intravascular ultrasound (ivus), a 4.00mm x 8mm synergy drug-eluting stent was deployed for treatment.Post-dilatation was performed with a 5.5x8.0 nc emerge balloon catheter.To check stent expansion, ivus was performed which revealed that the stent needed additional post-dilatation.After ivus removal, the stent dislodged and was last seen in the ascending aorta.The stent was not found under fluoroscopy and was not retrieved.It was confirmed the stent was not in the carotids or left ventricle.A second stent was successfully deployed in the lmca and the procedure was completed.There were no patient complications reported and the patient's status was stable.

• 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: 8668024
• Report Number: 2134265-2019-05866
• Device Sequence Number: 2292953
• Product Code: NIQ
• UDI-Device Identifier: 08714729840015
• UDI-Public: 08714729840015
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/04/2019

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: 11/11/2020
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0022975214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: Other