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

Model Number 10607

Device Problem Obstruction of Flow (2423)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that chest pain, st elevation, stent thrombosis, vessel no-flow, and cardiac arrest occurred.The target lesions were located in the proximal left anterior descending artery (p-lad) and proximal right coronary artery (p-rca).Patient was given plavix, aspirin and 10,000 units of heparin during the procedure.Activated clotting time was in the therapeutic range to 78.A 3.00 x 38 synergy ii stent was successfully implanted in the p-lad and post-dilatation was performed by a 3.25 x 15 nc emerge balloon catheter.Post-angiogram was performed and results were great.Subsequently, a 3.0 x 16 synergy ii stent was advanced and implanted in the p-rca.However, within the hour the patient was in the post-recovery unit, patient complained of chest pain and st elevation was noted.Angiogram was performed in the stented area where the stents were implanted and stent thrombosis was noted.The whole vessel had closed and thrombolysis in myocardial infarction(timi) flow was down to zero and patient had arrested code blue.Patient was placed on a non-bsc support device, followed by extracorporeal membrane oxygenation (ecmo).The clot within the stent was removed with an angiojet catheter and was post-dilated.No further complications were reported and the patient's status was finally stable and ambulatory.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7838041
• MDR Text Key: 118924960
• Report Number: 2134265-2018-60610
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022211918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention