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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10607
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/11/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 38 synergy ii drug eluting coronary stent was selected for used.However, prior of entering it to the body the stent delivery system was broken.The procedure was completed with different device.There were no patient complications reported.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
MDR Report Key12751597
Report Number2134265-2021-13877
Device Sequence Number1453931
Product Code NIQ
UDI-Device Identifier08714729840428
UDI-Public08714729840428
Combination Product (Y/N)Y
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/07/2023
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0027160151
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/29/2021
Initial Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured04/07/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient Age51 YR
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