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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 H7493926024300
Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that stent dislodgment occurred.The target lesion was located in the left anterior descending (lad) artery.A 3.00 x 24 synergy ii drug-eluting stent was deployed to treat the lesion.However, when the physician went to post-dilate, it was realized that the stent was not implanted.Intravascular ultrasound (ivus) was performed and it was confirmed that the stent was not implanted and could not be seen anywhere inside the patient's body.The procedure was completed with another synergy stent.The physician suspects the stent was not on the delivery system when the device was inserted into the patient.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A review of the manufacturing data was performed and the maximum crimped stent profile at the time of manufacture was within the specification.This data verifies that the stent was crimped on the balloon catheter during the manufacturing process.The stent had detached from the sds and was not returned for analysis.100% final inspection is carried out before sterile packaging.The stent most likely went missing at the customer¿s facility.Stent detachment most likely occurred due to handling during unpacking and/or preparation.A visual examination of the bumper tip showed no signs of damage.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were relaxed from their original folded position appearing as if positive pressure and negative pressure was applied.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the shaft polymer extrusion.The 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 most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was reported that stent dislodgment occurred.The target lesion was located in the left anterior descending (lad) artery.A 3.00 x 24 synergy ii drug-eluting stent was deployed to treat the lesion.However, when the physician went to post-dilate, it was realized that the stent was not implanted.Intravascular ultrasound (ivus) was performed and it was confirmed that the stent was not implanted and could not be seen anywhere inside the patient's body.The procedure was completed with another synergy stent.The physician suspects the stent was not on the delivery system when the device was inserted into the patient.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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6368826
MDR Text Key68748944
Report Number2134265-2017-01396
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840237
UDI-Public(01)08714729840237(17)20171010(10)19853174
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,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/10/2017
Device Model NumberH7493926024300
Device Catalogue Number39260-2430
Device Lot Number19853174
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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