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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 H7493926248250
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).
 
Event Description
It was reported that stent damage occurred.The target lesion was located in a calcified right coronary artery (rca).A 2.50x48mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion.The device was removed and it was noted that the stent struts were crimped.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: synergy ous, mr, 2.5x48mm, stent delivery system was returned for analysis.A visual examination of the crimped stent found distal stent damaged.Struts were stretched distally over the distal tip.It is likely the crimped stent may have encountered resistance and subsequent damage during the attempt to withdraw the device.The undamaged proximal stent outer diameter was measured and was within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.A visual examination of the balloon cones was performed 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 found multiple hypotube kinks along the catheter length.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issue with the shaft polymer extrusion profile.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.No other issues noted during analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
It was reported that stent damage occurred.The target lesion was located in a calcified right coronary artery (rca).A 2.50x48mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion.The device was removed and it was noted that the stent struts were crimped.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
SYNERGY¿
Type of Device
CORONARY 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 Key7130913
MDR Text Key95946921
Report Number2134265-2017-12565
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeSG
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/24/2018
Device Model NumberH7493926248250
Device Catalogue Number39262-4825
Device Lot Number20474856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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