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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 H7493926220350
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: synergy ous mr 3. 50 x 20mm stent delivery system was returned for analysis. An examination of the crimped stent revealed stent damage. Distal struts 1-8 were undamaged; the remainder of the struts were damaged and bunched in a distal direction. The undamaged crimped stent outer diameter was measured and the result was within the specification. The balloon cones were reviewed and there were no issues to note. The balloon wings were tightly wrapped and evenly folded. A visual and tactile examination of the hypotube revealed no issues. An examination of the shaft polymer extrusion found no issues. There were no signs of damage or strain to the port bond. The tip was visually examined and no issues were noted. No other issues were identified during the product analysis. 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. Coronary angiography was performed which revealed an 87% stenosed target lesion located in the moderately tortuous and severely calcified mid left anterior descending artery. After a non-bsc guide wire crossed the lesion, pre-dilatation was performed using a 3. 0 x 15 non-bsc balloon catheter. A 3. 50 x 20 synergy¿ drug-eluting stent was then advanced but failed to cross the lesion due to the calcification and the distal stent strut was damaged. The device was removed and the procedure was completed with another 3. 50 x 20 synergy¿ drug-eluting stent, followed by post-dilatation using an nc emerge balloon catheter. No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is combination product. (b)(4).
 
Event Description
It was reported that stent damage occurred. Coronary angiography was performed which revealed an 87% stenosed target lesion located in the moderately tortuous and severely calcified mid left anterior descending artery. After a non-bsc guide wire crossed the lesion, pre-dilatation was performed using a 3. 0 x 15 non-bsc balloon catheter. A 3. 50 x 20 synergy¿ drug-eluting stent was then advanced but failed to cross the lesion due to the calcification and the distal stent strut was damaged. The device was removed and the procedure was completed with another 3. 50 x 20 synergy¿ drug-eluting stent, followed by post-dilatation using an nc emerge balloon catheter. 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 Key7154099
MDR Text Key251251097
Report Number2134265-2017-12896
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/15/2018
Device Model NumberH7493926220350
Device Catalogue Number39262-2035
Device Lot Number19883911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2016
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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