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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 10604
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

Reportable based on device analysis completed on 19-dec-2018. It was reported that difficulty loading wire occurred. During introduction of a 2. 25 x 24mm synergy ii drug-eluting stent into the wire, the device would not go over the wire. Another 2. 25 x 24mm synergy stent was used and the procedure was completed. No patient complications or injuries were reported. However, returned device analysis revealed a stent damage. A synergy ii us mr 2. 25 x 24mm stent delivery system (sds) was returned for analysis without a stent. A visual and microscopic examination of the crimped identified stent damage. The crimped stent outer diameter (od) of the undamaged section of the crimped stent was measured and is within max crimped stent profile measurement. The balloon was reviewed and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. A visual and tactile examination of the hypotube found multiple hypotube kinks. A visual and tactile examination of the shaft polymer extrusion revealed no issues. The device was loaded onto and tracked over a 0. 014 guidewire without issue. A visual and microscopic examination found damage to the tip. No other issues were identified during the product analysis.

 
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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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8156767
MDR Text Key130187504
Report Number2134265-2018-63617
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 12/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/10/2019
Device MODEL Number10604
Device Catalogue Number10604
Device LOT Number0022035056
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/06/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/10/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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