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

Model Number	10606
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)
Date of Event	03/29/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that hypotension, thrombosis, and death occurred.The target lesions were located in the 85% stenosed moderately calcified left anterior descending artery (lad) and 75% stenosed non-calcified circumflex artery (cx).At the beginning of the procedure, the patient was hypotensive.A ventricular support device was used and procedure was continued.Following rotablation, three synergy drug eluting stents, a 3.00 x 32, a 3.00 x 8, and a 3.50 x 38 respectively were implanted, two in the lad and one in the cx.A non-boston scientific stent was also implanted in the cx.The procedure was completed and the patient was stable.When the ventricular support device was removed, the patient became hypotensive again.When the physician went back in with the guide, it was noted that all stents had stent thrombosis.Both the lad and cx arteries were closed off and the physician was unable to reopen either one.Cardiopulmonary resuscitation was performed but the patient did not survive.The official cause of death was coronary thrombus.No autopsy was performed.

• 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: 11676196
• Report Number: 2134265-2021-04556
• Device Sequence Number: 17036757
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0024833924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/15/2021
• 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: Death