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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926220300
Device Problems Balloon; Hole In Material
Event Date 04/25/2017
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. (b)(4).

 
Event Description

It was reported that balloon leakage occurred. The target lesion was located in the severely calcified proximal left anterior descending artery (lad). A 3. 00 x 20mm synergy¿ drug-eluting stent was advanced to treat the lesion. However, during initial dilation at 10 atmospheres for 25 seconds, a contrast agent seeped out from the balloon. The stent was implanted successfully and was well apposed. The stent balloon was pulled out without issue and the procedure was completed. No patient complications were reported and the patient¿s status was stable.

 
Manufacturer Narrative

Device evaluated by mfr: stent delivery system (sds) was returned for analysis. The stent was not returned for analysis. The balloon body was reviewed and the balloon wings appeared relaxed confirming that positive pressure was applied. As part of the analysis, inflation of the device was attempted. The returned device was attached to an encore inflation device and positive pressure was applied in an attempt to inflate the balloon. The balloon inflated to nominal pressure then subsequently to rated burst pressure without any issues noted and deflated within 6 seconds which is within specification. A visual examination of the bumper tip showed signs of damage at the distal edges of the tip. This type of damage is consistent with excessive force being applied on the delivery system. A visual and tactile examination found multiple kinks along several locations of the hypotube shaft. This type of damage is consistent with excessive force being applied on the delivery system. A visual and tactile examination found multiple kinks along several locations of the hypotube shaft. This type of damage is consistent with excessive force being applied on the delivery system. Visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion shaft. The bicomponent bond showed no signs of damage. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).

 
Event Description

It was reported that balloon leakage occurred. The target lesion was located in the severely calcified proximal left anterior descending artery (lad). A 3. 00 x 20mm synergy¿ drug-eluting stent was advanced to treat the lesion. However, during initial dilation at 10 atmospheres for 25 seconds, a contrast agent seeped out from the balloon. The stent was implanted successfully and was well apposed. The stent balloon was pulled out without issue and the procedure was completed. No patient complications were reported and the patient¿s status was stable.

 
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Brand NameSYNERGY¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6567447
Report Number2134265-2017-04731
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/18/2018
Device MODEL NumberH7493926220300
Device Catalogue Number39262-2030
Device LOT Number0020126357
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/08/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/16/2017
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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