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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 AVSM10080
Device Problems Material Separation (1562); Obstruction of Flow (2423)
Patient Problems Reocclusion (1985); No Consequences Or Impact To Patient (2199)
Event Date 01/28/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.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 instructions for use (ifu) is adequate for the reported device/patient code(s) 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.(expiry date: 09/2020).
 
Event Description
It was reported that approximately six days after the stent graft was successfully implanted the healthcare provider (hcp) was performing an intervention (unrelated to the device) to treat a cto and after successfully crossing the stent graft, after balloon angioplasty, the hcp identified via an angiogram that the inner layer of the epte coating was allegedly separated from the inner portion of the stent graft.Reportedly, the stent graft was implanted and the procedure was completed by catheter insertion in the right chest.There was no reported patient injury.
 
Event Description
It was reported that approximately six days after the stent graft was successfully implanted the healthcare provider (hcp) was performing an intervention (unrelated to the device) to treat a cto and after successfully crossing the stent graft, after balloon angioplasty, the hcp identified via an angiogram that the inner layer of the epte coating was allegedly separated from the inner portion of the stent graft.Reportedly, the stent graft was implanted and the procedure was completed by catheter insertion in the right chest.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: five x-ray images were returned for evaluation showing a stent placed in the cephalic arch.A coating separation of the stent graft as reported by the customer cannot be determined.The stent graft was found to be placed in a curved section of the vessel.A significant restenosis of the cephalic arch in the area of the placed stent graft could be identified.A device deficiency related to the re stenosis could not be identified; as reported by the customer, the stenosis was not related to the placed stent graft.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the issue experienced by the customer could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the correct stent graft deployment.Regarding pre- and post- dilation the ifu states: '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 of the target lesion requiring reintervention, pseudoaneurysm, vessel rupture, dissection, extravasation, perforation.
 
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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 Key8380040
MDR Text Key137559463
Report Number9681442-2019-00026
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741106408
UDI-Public(01)00801741106408
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,health
Type of Report Initial,Followup
Report Date 04/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAVSM10080
Device Catalogue NumberAVSM10080
Device Lot NumberANCW0272
Was Device Available for Evaluation? No
Date Manufacturer Received03/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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