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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10623
Device Problems Break (1069); Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.During insertion of a 3.5 x 38mm synergy ii drug-eluding stent resistance was encountered.The device was removed and a shaft break was noted.The procedure was successfully completed with a different device.
 
Manufacturer Narrative
Device is a combination product.A 3.50 x 38mm synergy stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured by snap gauge and the result was within max crimped stent profile measurement.The balloon was reviewed 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 of the hypotube identified a fracture in the lasercut region at 109.5 cm distal to the distal end of strain relief.A hypotube kink was also identified 23.5 cm distal to the distal end of strain relief.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues with the tip.No other issues were identified during the product analysis.
 
Event Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.During insertion of a 3.5 x 38mm synergy ii drug-eluding stent resistance was encountered.The device was removed and a shaft break was noted.The procedure was successfully completed with a different device.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9201983
MDR Text Key164846257
Report Number2134265-2019-12576
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0024012709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Date Manufacturer Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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