MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT

Catalog Number	AVFL08100
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 or Problem Description
It was reported that post a stent graft placement procedure at the cephalic arch, the stent had allegedly collapsed and flow was going around it.The current status of the patient was unknown.
Event or Problem Description
It was reported that post a stent graft placement procedure at the cephalic arch, the stent had allegedly collapsed and flow was going around it.Reportedly, the patient is still in bad pain but only two weeks post stenting.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, no lot number of the specific stent was reported.Investigation summary: the delivery system or the stent were not returned for evaluation.Multiple images were provided for evaluation; the images provided were taken from a computer monitor at an oblique angle and with limited quality.The monitor is showing angiographic images and x-ray from multiple days, prior to stent placement, after stent placement, balloon dilation and placement of an additional stent.Based on the images provided a device deficiency of the placed stent could not be identified.In this case, it was reported that the lesion was predilated prior to stent placement, the placed stent was post dilated.There were no reported issues during the initial stent placement procedure; the deformation of the stent was found one year after placement in the cephalic arch.Based on information available and x-ray images provided, the investigation is closed with inconclusive results.A definite root cause for the reported issue could not be identified.Labeling review: relevant labeling for this product was reviewed.Potential complications and adverse events were found to be referenced.The instructions for use (ifu) states that potential complications may include but are not limited to: new lesions in the access circuit requiring reintervention, thrombotic occlusion, restenosis of the target lesion requiring reintervention and others.Covered stent specific events that could be associated with clinical complications such as misplacement, migration, embolism, fracture, compression, kinking and insufficient covered stent expansion.Instructions for covered stent deployment were found to be described in the ifu.Regarding selection of the correct size of the covered stent the ifu states: "special care must be taken to ensure that an appropriately sized device is selected.In the case of a diameter difference between the inflow and the outflow end, utilize the following as the reference vessel depending on the type of access.For an av graft access, utilize the graft diameter and for an av fistula access, utilize the inflow vein diameter." b5, g3, h6 (patient, device, method, result, conclusion).

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21704674
• Report Number: 9681442-2025-00096
• Device Sequence Number: 20019981
• Product Code: PFV
• UDI-Device Identifier: 00801741106996
• UDI-Public: (01)00801741106996
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: AVFL08100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female