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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; VASCULAR STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT SYSTEM; VASCULAR STENT GRAFT Back to Search Results
Model Number AVSM07080
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, images were provided for evaluation.The investigation is confirmed for deformation of the covered stent.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
 
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model avsm07080 vascular stent graft allegedly experienced material deformation.This information was received from one source.The event involved a patient with no known impact to the patient.The age, weight and gender of the patient were not provided.
 
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Brand Name
COVERA VASCULAR COVERED STENT SYSTEM
Common Device Name
VASCULAR STENT GRAFT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key10271440
Report Number9681442-2020-00152
Device Sequence Number803575
Product Code PFV
UDI-Device Identifier00801741106255
UDI-Public(01)00801741106255
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) 07/14/2020
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 NumberAVSM07080
Device Catalogue NumberAVSM07080
Device Lot NumberANDV3546
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/14/2020
Patient Sequence Number1
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