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

Model Number	10604
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	06/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon removal difficulties were encountered and thrombosis occurred.The patient presented with st- elevation myocardial infarction.The target lesion was located in the mid left anterior descending.A 2.25 x 24mm synergy ii drug-eluting stent was deployed for treatment.After deployment, the balloon was deflated.However, upon removal, it was noted that the deflated balloon was stuck in the deployed stent.The physician pulled the guide into the left main and a few tugs of the delivery system were performed and finally, the deflated balloon was released.Immediately after the implantation, a thrombus was noted.A iib iiia inhibitor was then started and post dilatation at 16 atmospheres was performed with a 2.24x15 nc emerge balloon catheter and the procedure was completed.No patient complications were reported and the patient was doing well.

• 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: 8749852
• Report Number: 2134265-2019-07052
• Device Sequence Number: 1689725
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: 11/05/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022924424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/01/2019
• 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: Required Intervention
• Patient Age: 69 YR