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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number H7493926024270
Device Problems Bent (1059); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that removal difficulties and stent damage occurred.A 2.75 x 24mm synergy ii drug-eluting stent was advanced to treat the lesion.The device was removed to perform further dilatation.Upon removal, the device snagged on the guide catheter and the stent started to pull from the balloon and appeared to have folded over on itself.The guide catheter was pulled into the aorta and through wire manipulation, the device was removed.The procedure was completed with another stent of the same size.There were no patient complications.
 
Event Description
It was reported that removal difficulties and stent damage occurred.A 2.75 x 24mm synergy ii drug-eluting stent was advanced to treat the lesion.The device was removed to perform further dilatation.Upon removal, the device snagged on the guide catheter and the stent started to pull from the balloon and appeared to have folded over on itself.The guide catheter was pulled into the aorta and through wire manipulation, the device was removed.The procedure was completed with another stent of the same size.There were no patient complications.
 
Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: synergy ii us mr 2.75 x 24mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.The proximal end of the stent was bunched and pushed towards the mid-section of the stent.The distal section of the stent was undamaged.The undamaged distal crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The balloon cones were 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 device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and no issues were noted.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 caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
 
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Brand Name
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key7583640
MDR Text Key110583948
Report Number2134265-2018-05044
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840220
UDI-Public08714729840220
Combination Product (y/n)N
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/03/2018
Device Model NumberH7493926024270
Device Catalogue Number39260-2427
Device Lot Number0020861254
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Date Manufacturer Received07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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