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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10602
Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  Injury  
Event Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 3.50 x 16 synergy drug eluting stent was advanced for treatment.However, the stent was stripped from the delivery system and was lodged in the radial artery.The procedure was aborted and there were no patient complications reported.
 
Event Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 3.50 x 16 synergy drug eluting stent was advanced for treatment.However, the stent was stripped from the delivery system and was lodged in the radial artery.The procedure was aborted and there were no patient complications reported.It was further reported that vascular access was obtained via the radial artery and that the lesion was pre-dilated with a balloon.It was noted that there were multiple attempts made to position the stent at the lesion site.Device interaction with a previously deployed stent which caused the dislodgement was also noted.
 
Manufacturer Narrative
H6- patient codes: device embedded in tissue or plaque.H6- device codes: device-device incompatibility.
 
Manufacturer Narrative
H6 patient codes corrected.
 
Event Description
It was reported that stent dislodgement occurred.The target lesion was located in the circumflex artery.A 3.50 x 16 synergy drug eluting stent was advanced for treatment.However, the stent was stripped from the delivery system and was lodged in the radial artery.The procedure was aborted and there were no patient complications reported.It was further reported that vascular access was obtained via the radial artery and that the lesion was pre-dilated with a balloon.It was noted that there were multiple attempts made to position the stent at the lesion site.Device interaction with a previously deployed stent which caused the dislodgement was also noted.It was further reported via medwatch 2900390000-2021-8001 that the patient was brought emergently for st elevation myocardial infarction reperfusion.The patient underwent diagnostic coronary angiography, left heart catheterization, left ventriculogram, and percutaneous coronary intervention (pci).The stent was dislodged from the balloon in the ostial left circumflex artery.A vascular surgeon was consulted but no surgical intervention was required.The stent was left in the distal radial artery.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11163730
MDR Text Key226581457
Report Number2134265-2021-00133
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840121
UDI-Public08714729840121
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,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/08/2022
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0025761500
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/04/2021
Initial Date FDA Received01/13/2021
Supplement Dates Manufacturer Received01/27/2021
02/23/2021
Supplement Dates FDA Received02/17/2021
03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age52 YR
Patient Weight66
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