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

Device Problem Obstruction of Flow (2423)

Patient Problems ST Segment Elevation (2059); Thrombosis (2100); Blood Loss (2597)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that patient experienced hemodynamic de-compensation, st elevation and acute thrombosis occurred.The target lesions were located in the proximal, mid, and distal right coronary artery (rca).Subsequently, three synergy drug-eluting stents were implanted in the target lesions and the patient was given brilinta and heparin.However, 32 hours later, the patient was sent back to lab due to hemodynamic de-compensation, st changes and thrombosis was found in rca.The clot was extracted and integrilin was administered.No further complications were reported.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8745589
• MDR Text Key: 149551985
• Report Number: 2134265-2019-06860
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention