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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 10607
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that difficulty removal occurred.The target lesion was located in the right coronary artery.A 4.00 x 38 synergy drug-eluting stent was selected and placed.However, upon removal, the balloon would not re-wrap and would not go into the guide catheter.The physician used a new guide catheter and then removed all devices as a whole.The balloon was removed in a deflated state and completed the procedure.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device is a combination product.Bsc aware date corrected from 07/02/2020 to 07/03/2020.
 
Event Description
It was reported that difficulty removal occurred.The target lesion was located in the right coronary artery.A 4.00 x 38 synergy drug-eluting stent was selected and placed.However, upon removal, the balloon would not re-wrap and would not go into the guide catheter.The physician used a new guide catheter and then removed all devices as a whole.The balloon was removed in a deflated state and completed the procedure.No patient complications were reported and the patient's status was stable.It was further reported that the clacified lesion was pre-treated with coronary orbital atherectomy system and a non-compliant balloon before stenting.The balloon was inflated once at 20 atmospheres for 9 seconds after initial stent deployment.
 
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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 Key10305942
MDR Text Key199856936
Report Number2134265-2020-09087
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840435
UDI-Public08714729840435
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 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2021
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0024361060
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age42 YR
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