MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926020300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Edema (1820); Myocardial Infarction (1969)

Event Date 07/01/2018

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

Event Description

(b)(6).It was reported that myocardial infarction and death occurred.In (b)(6) 2017, the subject was referred for elective cardiac catheterization.Target lesion #1 was located in proximal right coronary artery (rca) with 95% stenosis and was 18 mm long with a reference vessel diameter of 3 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00 x 20 mm study stent.Following post dilatation, there was 0% residual stenosis.The subject was discharged on aspirin and ticagrelor.In (b)(6) 2018, the subject experienced shortness of breath at home and was found pulseless.The subject was unresponsive for five minutes.Emergency medical service (ems) initiated cardiopulmonary resuscitation (cpr) and provided medications.The ems achieved return of spontaneous circulation.The subject presented in the emergency department in cardiac arrest and was unresponsive.The subject was noted to have bradycardia and their end tidal carbon dioxide went down.The subject received medications and five more rounds of cpr.The advanced cardiovascular life support was restarted and was continued for about twenty minutes.The return of spontaneous circulation was never obtained and no cardiac activity was noted.The total downtime of the subject was roughly sixty minutes.Cause of death was cardiac arrest, likely due to myocardial infarction with flash pulmonary edema.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7715453
• MDR Text Key: 114876329
• Report Number: 2134265-2018-06606
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: H7493926020300
• Device Catalogue Number: 39260-2030
• Device Lot Number: 0020808554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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): Death
• Patient Age: 75 YR