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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 H7493926238350
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that stent damage occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified mid to distal right coronary artery (rca).Following pre-dilatation, a 3.50x38mm synergy¿ stent was advanced to treat the target lesion.However, the device was unable to cross the ostium part of rca and when the device was removed, it was noted that the middle part of the stent was bent.The procedure was completed with a non-bsc stent.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 Key7625444
MDR Text Key111892236
Report Number2134265-2018-05856
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/13/2019
Device Model NumberH7493926238350
Device Catalogue Number39262-3835
Device Lot Number21787965
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2018
Initial Date FDA Received06/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/14/2018
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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