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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 AVSM10100
Medical Device Problem Codes Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number was provided, a lot history review was performed.The device was returned to the manufacturer for evaluation.The investigation is confirmed for outer sheath fracture which made a successful deployment impossible.The definite root cause could not be determined based on the available information.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 avsm10100 covera vascular covered stent system allegedly experienced broken sheath and failed to deploy.This information was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) lbs.
 
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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 Key10271736
Report Number9681442-2020-00154
Device Sequence Number10963405
Product Code PFV
UDI-Device Identifier00801741106415
UDI-Public(01)00801741106415
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 NumberAVSM10100
Device Catalogue NumberAVSM10100
Device Lot NumberANDW3051
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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