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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 H7493926038350
Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 11/27/2019
Event Type  Death  
Event Description

An elderly female patient with history of hypertension (htn), chest pain, recent traffic accident with t12 compression fracture and right (r) sided rib fractures presents to the hospital. While having a cardiac catheterization, the stent deployed in the left anterior descending (lad) artery. Unable to remove delivery balloon/ catheter. While attempting to remove, balloon tip fractured. Attempts made to snare and remove balloon. Pt coded. Balloon eventually retrieved. Unable to resuscitate patient expired. Procedure: cardiac cath. "we were able to take the wire out but not the balloon which was stuck in the sever instant restenosis of the proximal left anterior (la) stent which is likely under expanded. I tried to use another coronary wire but could not pass by the balloon which was in the lad. We pulled the balloon hard and shaft broke with balloon still stuck in the lad stent. Patient had a pulseless electrical activity (pea) arrest and we took long sumariai wire and formed a snare through guide catheter to retrieve the stuck balloon and its shaft. There was no residual material were left in place afterwards. ".

 
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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
MDR Report Key9457971
MDR Text Key170460805
Report Number9457971
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH7493926038350
Device Catalogue NumberH7493926038350
Device LOT Number24425786
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/03/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/04/2019
Event Location Hospital
Date Report TO Manufacturer12/12/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/12/2019 Patient Sequence Number: 1
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