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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT SYSTEM Back to Search Results
Catalog Number AASME10040
Device Problem Obstruction of Flow (2423)
Patient Problem Stenosis (2263)
Event Date 07/02/2020
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: 08/2021).The catalog number identified has not been cleared in the us, but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified.
 
Event Description
It was reported that a stent was found occluded during a 30 days follow up.The stent has been placed in the left common iliac artery via ipsilateral approach, during kissing stent placement.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.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.Investigation summary: the sample was not returned to manufacturer for evaluation.The stent remains implanted.X-ray images were provided.However, no device deficiency or any lack of performance of the placed stent could be confirmed.In this case pre dilation as well as post dilation was performed; there was no report of any irregularities or complication during initial stent placement.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instruction for use complications and adverse events associated with the use of the covera plus vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes restenosis of the target vessel.Regarding pre and post dilation the instruction for use 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.Avoid balloon dilation in the healthy, non-stenosed segment of the vessel." h10: d4 (expiry date: 08/2021).H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the covera vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent system products are identified in d2 and g5.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 a stent was found occluded during a 30 days follow up.The stent has been placed in the left common iliac artery via ipsilateral approach, during kissing stent placement.There was no reported patient injury.
 
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Brand Name
COVERA PLUS 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 Key10324986
MDR Text Key200631034
Report Number9681442-2020-00185
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741136016
UDI-Public(01)00801741136016
Combination Product (y/n)N
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,study
Type of Report Initial,Followup
Report Date 11/10/2020
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? Yes
Device Operator Health Professional
Device Catalogue NumberAASME10040
Device Lot NumberANDV1994
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/03/2020
Initial Date FDA Received07/27/2020
Supplement Dates Manufacturer Received10/21/2020
Supplement Dates FDA Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient Weight90
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