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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10607
Device Problems Fracture (1260); Device Damaged by Another Device (2915)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 09/15/2020
Event Type  Injury  
Event Description

It was reported that the stent was damaged post-deployment, fractured, and left unretrieved device fragments requiring additional intervention. The target lesion was located in the distal left anterior descending artery (lad). A 2. 25x38mm synergy ii drug-eluting stent was deployed in the lad over a non-bsc guidewire. A 3x20mm synergy was then inserted over the same non-bsc guidewire in the lad but failed to cross through the deployed stent. The 3x20mm undeployed stent was removed and a 3x15 emerge balloon was then advanced for stent post dilation. Another non-bsc guidewire was passed down the lad through the deployed stent as a buddy wire. Another attempt to cross through the previous deployed stent with the 3x20mm synergy stent once again failed. The two non-bsc guidewires were then removed with resistance and found to be damaged. Also, a part of the deployed stent was entangled in them. The stent had fractured and some of the stent remained behind in the lad. A new non-bsc guidewire was then inserted through the deployed stent and a 2. 5x30mm non-bsc balloon was used for dilation in the lesion/stent area, then a 2x30mm emerge balloon was used. Two non-bsc stents were then deployed in the distal lad, crushing the remaining stent. Post-procedure echocardiogram was negative and the patient was transferred from cath lab pain free.

 
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Brand NameSYNERGY
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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 Key10653281
MDR Text Key210572564
Report Number2134265-2020-13456
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10607
Device Catalogue Number10607
Device LOT Number0025142030
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 Received09/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/21/2020
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: 10/08/2020 Patient Sequence Number: 1
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