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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 H7493926216300
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product. (b)(4). Synergy mr, ous, 3. 0 x 16mm, stent delivery system was returned for analysis. A visual examination of the crimped stent found stent struts around the mid-section stent moving towards the distal section were damaged. Stent appeared bent with stent struts slightly opening. The undamaged stent outer diameter was measured which is 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 no issue with the hypotube. A visual and tactile examination found no issue with the extrusion. The bi-component bond showed no signs of damage or strain. A visual and tactile examination found damage to the tip. The type of damage evident is consistent with resistance being encountered during advancement. No other damage noted during 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
Reportable based on device analysis completed on 11-dec-2017. It was reported that crossing difficulties were encountered. The target lesion was located in the severely tortuous and severely calcified left anterior descending artery. Following pre-dilation, a 3. 00 16mm synergy¿ drug-eluting stent was advanced to treat the lesion. However, the device was unable to cross the lesion due to calcification and angulation. The procedure was completed with another with the same device. No patient complications were reported and patient's status was good. However, returned device analysis revealed stent damage.
 
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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 Key7151353
MDR Text Key96117087
Report Number2134265-2017-12650
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,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2018
Device Model NumberH7493926216300
Device Catalogue Number39262-1630
Device Lot Number19881612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
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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