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

Catalog Number	AVFM08060
Medical Device Problem Codes	Misfire (2532); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide by bd represents all 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
On (b)(6) 2025, a patient underwent a stent placement procedure using covera vascular stent.During procedure, the stent narrowed and did not fully open on the distal end.There was no issue with the release of the stent off the sheath.The stent was then completely effaced with an 8 balloon and after the balloon was deflated the stent remained compressed and not fully opened, per customer it looks to be twisted in the vessel and not seated into the vessel wall.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure using covera vascular stent for the indication of stent placement was a stenosis at the basilic swing point to the axillary vein.During the procedure.It was reported that a 8x60mm stent narrowed and the distal end did not fully open.There was no issue with the release of the stent off the sheath.Even though the stent was post dilated with an 8mm balloon, the stent remained compressed and did not fully opened after balloon deflation.The stent appeared twisted in the vessel and not properly seated to the vessel wall.There was no reported patient injury.
Additional Manufacturer Narrative
H11: 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, 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: no x-ray images of the placed stent were provided for evaluation.Therefore, the reported stent deformation or twisting of the stent could not be verified.Based on information available, the investigation is closed with inconclusive result.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 instruction for use 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 correct deployment of the covered stent were found to be described in the instruction for use.Regarding selection of the correct size of the covered stent the instruction for use 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." g3, h6 (device, method, result, conclusion) section a through f ¿ the information provide by bd represents all 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.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: VASCULAR COVERED STENT GRAFT
• 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: 23566255
• Report Number: 9681442-2025-00369
• Device Sequence Number: 21396490
• Product Code: PFV
• UDI-Device Identifier: 00801741106514
• UDI-Public: (01)00801741106514(17)261212(10)ANJZ1609
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AVFM08060
• Device Lot Number: ANJZ1609
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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
• Patient Sex: Unknown