MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTE SYNERGY II; CORONARY DRUG-ELUTING STENT

Model Number H7493926020220

Device Problem Premature Activation (1484)

Patient Problems Cardiac Arrest (1762); Death (1802); Cardiogenic Shock (2262)

Event Date 10/24/2016

Event Type  Injury  

Event Description

Patient came in as cardiac alert.While attempting to advance the synergy stent past the diagonal lesion, the stent started coming off of the balloon.Attempted to retrieve stent and ended up deploying the synergy stent unintentionally.The patient suffered a cardiac arrest while in the cath lab.Return of spontaneous circulation (rosc) was able to be achieved but the patient remained in cardiogenic shock and was transferred to the icu and expired a short time later.

• Brand Name: SYNERGY II
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTE; 500 commander shea boulevard; quincy MA 02171
• MDR Report Key: 6085141
• MDR Text Key: 59387654
• Report Number: 6085141
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/05/2017
• Device Model Number: H7493926020220
• Device Lot Number: 19245828
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 83