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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 AVSM07060
Medical Device Problem Codes Break (1069); Retraction Problem (1536)
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 lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation of the device confirmed retraction problem and break thereby confirming the alleged malfunction.Based upon the available information, the definitive root cause for this event 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 covered stent system allegedly experienced break and retraction problem.This information was received from one source.The malfunction had patient involvement but the patient had no consequences.The age and weight of the male patient 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 Key10276469
Report Number9681442-2020-00167
Device Sequence Number19391637
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 NumberANDT4100
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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