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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 AVSM07060
Medical Device Problem Codes Positioning Failure (1158); Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the investigation is inconclusive for the reported positioning failure, failure to advance, and positioning problem.Based upon the available information, a definitive root cause is unknown.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 avsm07060 vascular stent graft allegedly experienced positioning failure, failure to advance, and positioning problem.This information was received from a single source.The malfunction involved a patient with no reported consequences.The patient¿s age, weight, and sex 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 Key10277225
Report Number9681442-2020-00170
Device Sequence Number19391638
Product Code PFV
UDI-Device Identifier00801741106248
UDI-Public(01)00801741106248
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) 07/15/2020
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 NumberAVSM07060
Device Catalogue NumberAVSM07060
Device Lot NumberANDS4746
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/15/2020
Patient Sequence Number1
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