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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10619
Device Problem Fracture
Event Date 10/14/2019
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. The patient presented with myocardial infarction. Vascular access was obtained via the right femoral artery. The 70% stenosed, concentric, de novo target lesion with a bend between 45 and 90 degrees was located in the moderately tortuous and severely calcified left anterior descending artery. Following pre-dilatation using 2. 0x15mm and 2. 5x15mm nc emerge balloons, intravascular ultrasound (ivus) was done to assess the vessel. Further dilatation was done with a 2. 75x15mm nc emerge balloon and a 3. 0x12mm non-bsc lithotripsy balloon but the latter failed to deliver continuous pulses. Subsequently, a 2. 50x20mm synergy ii drug-eluting stent was introduced with significant resistance encountered during both advancing and operation. Before the stent was deployed at the target lesion. Post-dilatation was performed with the same 2. 75x15mm nc emerge balloon and with a new 3. 0x12mm non-bsc lithotripsy balloon but the latter failed to deliver continuous pulses again. Post ivus, the physician decided to post-dilate with a 3. 0x15mm non-bsc super high pressure balloon; however, after a second inflation at 25 atmospheres, it was noticed via imaging that the stent appeared to be fractured. No further patient complications were reported and the patient was stable.

 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI 
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9253160
Report Number2134265-2019-13012
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10619
Device Catalogue Number10619
Device LOT Number0023708926
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/23/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/29/2019 Patient Sequence Number: 1
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