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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 AVFM08040
Device Problem Obstruction of Flow (2423)
Patient Problem Stenosis (2263)
Event Date 01/14/2019
Event Type  Injury  
Manufacturer Narrative
Review of manufacturing records was not performed, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported through the results of a clinical trial approximately eight months post index procedure, 50% stenosis lesion was identified.It was further reported re-intervention was performed with successful result.It was further reported during 24-month follow-up, stenosis was identified, and standard pta was used to treat the lesion.
 
Manufacturer Narrative
The purpose of this supplement is to correct fda rn number.Review of manufacturing records was not performed, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported through the results of a clinical trial approximately eight months post index procedure, 50% stenosis lesion was identified.It was further reported re-intervention was performed with successful result.It was further reported during 24-month follow-up, stenosis was identified, and standard pta was used to treat the lesion.
 
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Brand Name
COVERA VASCULAR COVERED STENT SYSTEM
Type of Device
VASCULAR COVERED STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key8794458
MDR Text Key151171886
Report Number2020394-2019-01524
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741106507
UDI-Public(01)00801741106507
Combination Product (y/n)N
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/03/2017
Device Model NumberAVFM08040
Device Catalogue NumberAVFM08040
Device Lot NumberANAS0134
Was Device Available for Evaluation? No
Date Manufacturer Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASPIRIN; ASPIRIN; HEPARIN; HEPARIN; TPA; TPA; ASPIRIN; HEPARIN; TPA
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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