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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 AVFM08060
Device Problems Obstruction of Flow (2423); Appropriate Term/Code Not Available (3191)
Patient Problem Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
Medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.
 
Event Description
It was reported that during a covered stent placement procedure within the cephalic arch, the patient allegedly experienced thrombosis after post dilating the covered stent.It was further reported that the clot was removed from within the stent.The patient was reportedly stable post clot removal.
 
Manufacturer Narrative
H10: manufacturing review: the lot history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical sample was not available; x-ray images were provided documenting the placed covered stent including flow obstruction.However, an indication for an irregular placement or a defect of the placed stent could not be found.An indication for a device relation of the flow obstruction could not be determined.Therefore, the investigation of this issue is closed with inconclusive result.Based on the information available a definite root cause for the event reported could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential issue.Regarding pre- and post- dilation, the ifu state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated' and 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.' the ifu further state 'potential complications may include, but are not limited to: thrombotic occlusion, restenosis requiring reintervention (.)'.Holding and handling of the system throughout deployment was found sufficiently described.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that during a covered stent placement procedure within the cephalic arch, the patient allegedly experienced thrombosis after post dilating the covered stent.It was further reported that the clot was removed from within the stent.The patient was reportedly stable post clot removal.
 
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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 Key9175423
MDR Text Key162457430
Report Number9681442-2019-00157
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741106514
UDI-Public(01)00801741106514
Combination Product (y/n)N
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/18/2021
Device Model NumberAVFM08060
Device Catalogue NumberAVFM08060
Device Lot NumberANDN1872
Was Device Available for Evaluation? No
Date Manufacturer Received11/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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