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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 AVFM09060
Device Problem Obstruction of Flow (2423)
Patient Problems Swelling (2091); Stenosis (2263)
Event Date 09/20/2018
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 4-months post index procedure, target lesion stenosis and patient experienced arm and hand swelling was identified.Standard pta was performed with successful result.It was further reported that approximately one-year 4-month post index procedure, target lesion stenosis was identified.Standard pta was performed with successful result.The study was completed on (b)(6) 2019.
 
Event Description
It was reported through the results of a clinical trial approximately 4-months post index procedure, target lesion stenosis and patient experienced arm and hand swelling was identified.Standard pta was performed with successful result.It was further reported that approximately one-year 4-month post index procedure, target lesion stenosis was identified.Standard pta was performed with successful result.The study was completed on 04-feb-2019.
 
Manufacturer Narrative
After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is 9681442.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.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.
 
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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 Key8795514
MDR Text Key151204636
Report Number2020394-2019-01528
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741106552
UDI-Public(01)00801741106552
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAVFM09060
Device Catalogue NumberAVFM09060
Device Lot NumberANAW0679
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/21/2019
Initial Date FDA Received07/16/2019
Supplement Dates Manufacturer Received07/18/2019
Supplement Dates FDA Received07/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HEPARIN; HEPARIN; HEPARIN
Patient Outcome(s) Required Intervention;
Patient Age46 YR
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