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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 10623
Device Problems Break; Deflation Problem; Fracture; Difficult to Remove; Failure to Advance; Material Deformation
Event Date 12/18/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(6). Device is a combination product.

 
Event Description

It was reported that difficulty removal, shaft break, deflation failure requiring surgical intervention, stent damage and stent fracture occurred. The target lesion was a chronic totally occluded (cto) vessel near the mid right coronary artery (rca). Multiple guidewires were used to attempt to cross the lesion. A guidewire was finally successfully passed through the lesion area, and externalization was performed. Pre dilatation was done 12 times at 6 -12atm using a non bsc device, 5 times at 6atm using an emerge 2. 5x12 balloon catheter and 5 times at 6 - 14atm using another non bsc balloon catheter. A 2. 25 x 38 synergy drug eluting stent was advanced but failed to cross the lesion so pre dilatation was performed again. The 2. 25 x 38 synergy drug eluting stent was advanced again and was able to be positioned in the lesion. The 2. 25 x 38 synergy drug eluting stent was inflated multiple times at 11 atmospheres and was pulled slightly, then inflation was attempted again at 14 atmospheres. At which time it was noticed that the stent delivery (sds) system was unable to be removed. The sds could be advanced/pushed, so it was inflated again at 11atm and 16atm, but the balloon could not be deflated completely and the sds still could not be removed from the patient. The physician tried to inserting a non bsc guideliner, but was unable to pass through the lesion. The sds was pulled but the shaft separated. Intervention was attempted using a snare but the snare was unable to advance. So a 6fr multi-purpose catheter was advance up to the balloon, and the balloon part was dilated using a non bsc balloon catheter. The physician then attempted to pull the balloon and the stent, but the sds could not be retrieved. Retrieval attempts were stopped and the patient had to have the sds along with the implanted stent surgically removed. It was observed the stent was damaged and fractured. The patient then underwent a bypass procedure due to the cto lesion. The patient has been hospitalized and is in the intensive care unit (icu).

 
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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 IRELAND LIMITED
ballybrit business park
galway
EI 
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8236413
Report Number2134265-2018-65001
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/04/2019
Device MODEL Number10623
Device Catalogue Number10623
Device LOT Number0022237783
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/02/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/07/2018
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: 01/10/2019 Patient Sequence Number: 1
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