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

Model Number	10620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Device is a combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that a dissection occurred.In (b)(6) 2020, the subject experienced continuous runs of ventricular tachycardia and ventricular fibrillation requiring defibrillation by his implantable cardioverter defibrillator (icd), which did not respond to changes in medication.Coronary angiography revealed a 95% stenosed proximal right coronary artery (rca) which was treated with the placement of a 5.0x24mm study stent.Following stent placement, a dissection in the distal edge of the rca was noted and treated with placement of another 5.0x12mm study stent.In addition, the 90% stenosed proximal and mid left anterior descending artery (lad) were treated with placement of 4.0 x 28 mm and 3.5 x 38 mm synergy stents respectively in overlapping manner and the 90% stenosed posterior descending artery (pda) was treated with a 3.0 x 20 mm synergy stent.While treating the proximal lad with the 4.0 x 28 mm synergy stent, the first diagonal artery was jailed and had a timi flow of 0.Further intervention was deferred.Two days later the subject had mild shortness of breath with heaviness on his chest and was also noted to have low blood pressure.The subject became unresponsive and despite multiple antiarrhythmics, including lidocaine, amiodarone and procainamide, the subject continued to be in refractory ventricular tachycardia and ventricular fibrillation.Despite extensive cardiac resuscitation, the subject was pronounced dead the next day.

• 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: 9722030
• Report Number: 2134265-2020-01470
• Device Sequence Number: 361930
• Product Code: NIQ
• UDI-Device Identifier: 08714729973454
• UDI-Public: 08714729973454
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2020
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0022909315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/18/2020
• 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
• Patient Age: 55 YR