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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 H7493926038270
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 06/22/2016
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Event Description
It was reported that a foreign matter was found on the device.During preparation of a 2.75 x 38 synergy ii drug-eluting stent, it was noted that there were fibers on the mid section of the stent.The device never entered the patient's body and the procedure was completed with another 2.75 x 38 synergy ii drug-eluting stent.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found the stent damaged with struts from the 12th proximal row onwards stretched, distorted and bunched.The stent stretched over the distal markerband.Based on the analysis performed, the damage most likely occurred due to mishandling during preparation.It was reported that the physician noticed fibres on the mid-section of the stent however no foreign matter was visible during examination.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.The bumper tip of the device showed no signs of damage.A visual and tactile examination found several kinks along the hypotube shaft.A visual and tactile examination of the midshaft section found one kink at 97mm proximal of the port entry site.The outer extrusion, inner lumen and bi-component bond showed no signs of damage or strain.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
It was reported that a foreign matter was found on the device.During preparation of a 2.75 x 38 synergy ii drug-eluting stent, it was noted that there were fibers on the mid section of the stent.The device never entered the patient's body and the procedure was completed with another 2.75 x 38 synergy ii drug-eluting stent.No patient complications were reported and the patient's status was fine.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5806670
MDR Text Key49915886
Report Number2134265-2016-06249
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/13/2017
Device Model NumberH7493926038270
Device Catalogue Number39260-3827
Device Lot Number0019166410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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