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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 H7493926232350
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
Device is combination product.(b)(4).
 
Event Description
It was reported that stent damage occurred.The target lesion was located in a coronary vessel.A 3.50 x 38mm synergy¿ drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent strut was lifted.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Upn- search corrected from h7493926238350 - synergy ous mr 3.50 x 38 - 39262-3835 to h7493926232350 - synergy ous mr 3.50 x 32 - 39262-3235.Upn corrected from h7493926238350 to h7493926232350.Catalog/model # corrected from 39262-3835 to 39262-3235.Device lot number corrected from 21787965 to 20884684.Device expiration date corrected from 08/13/2019 to 01/01/2019.Device manufactured date corrected from 02/14/2018 to 07/25/2017.Device evaluated by mfr: eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: synergy ous mr 3.50 x 32mm stent delivery system (sds); 20868326-070 was returned for analysis.A visual and microscopic examination of the crimped stent identified distal stent damage.The distal end of the stent is damaged with stent struts lifted and pulled in a proximal direction.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and folded with some bunching was noted to the proximal balloon cone.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found damage to the tip.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 investigation conclusion is operational context as the product meets the design & 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 coronary vessel.A 3.50 x 38mm synergy¿ drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent strut was lifted.The device was completely removed from the patient and 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
MDR Report Key7636027
MDR Text Key112310652
Report Number2134265-2018-05987
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
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2019
Device Model NumberH7493926232350
Device Catalogue Number39262-3235
Device Lot Number20884684
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Date Manufacturer Received07/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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