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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT SYSTEM Back to Search Results
Model Number AVSM08100
Medical Device Problem Codes Difficult or Delayed Positioning (1157); Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned to the manufacturer for evaluation.Therefore, the investigation is inconclusive for difficult, or delayed positioning, and material deformation issue.The definitive root cause could not be determined based upon available information.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model avsm08100 vascular stent allegedly experienced difficult, or delayed positioning and material deformation.The information was received from a single source.One patient was involved with no reported patient injury.The device was used in a male patient, however, age and weight was not provided.
 
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Brand Name
COVERA VASCULAR COVERED STENT SYSTEM
Common Device Name
VASCULAR COVERED STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key10722807
Report Number9681442-2020-00220
Device Sequence Number11578592
Product Code PFV
UDI-Device Identifier00801741106316
UDI-Public(01)00801741106316
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/22/2020
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 No Information
Device Model NumberAVSM08100
Device Catalogue NumberAVSM08100
Device Lot NumberANDW3489
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/22/2020
Patient Sequence Number1
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