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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 Problems Fracture (1260); Migration (4003)
Patient Problems Insufficiency, Valvular (1926); Pulmonary Edema (2020); Prolapse (2475); Aortic Dissection (2491); No Code Available (3191)
Event Date 06/15/2020
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that aortic dissection, pulmonary edema and stent fracture occurred. The patient presented within 1 hour of onset of acute central chest pain. She was in shock, blood pressure(bp) 78/50, heart rate 80 regular with no discrepancy of bps from left and right arms. There were no signs of pulmonary edema. Emergent coronary angiogram revealed two target lesions. One lesion was a discrete ostial stenosis of 50-60% in the left main stem(lms) and the second lesion was a discrete ostial and proximal stenosis of 70% in the right coronary artery(rca). A 4. 00 x 16 synergy drug eluting stent was implanted in the lms and a 4. 00 x 20 synergy drug eluting stent was implanted in the rca. On table echocardiogram showed mild hypokinesia in the interventricular septum(ivs) and anterior walls. Color doppler assessment of the valves was not performed but angiographic findings suggested mild aortic regurgitation. Percutaneous coronary intervention(pci) to both lms and rca was performed successfully with no immediate complications. The patient was weaned off inotropic support within 12 hours. However, three hours post pci the patient developed pulmonary edema. An echocardiogram was performed and revealed severe aortic regurgitation (likely acute with no left ventricular dilatation), a possible dissection flap in the right sinus of valsalva and possible migration of the right coronary stent into the right sinus of valsalva. Left ventricular ejection fraction(lvef) was 45-50%, same as pre-pci finding. The patient was then transferred to another hospital for aortic valve, aortic root and ascending aorta repair. Intraoperative findings included spiral dissection in the root and ascending aorta, originating from the left and right coronary ostia; severe prolapse of the aortic cusps and both stents protruded about 1cm into the sinus. Lastly, both stents were surgically removed and appeared cracked and broken after removal from the coronary arteries. The patient had aortic valve replacement and was doing well post procedure.
 
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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 Key10312864
MDR Text Key200067128
Report Number2134265-2020-09227
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2021
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0024942777
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2019
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: 07/23/2020 Patient Sequence Number: 1
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