MAUDE Adverse Event Report: Angiomed GmbH & Co. Medizintechnik KG Covera Vascular Covered Stent; Vascular Covered Stent Graft

Catalog Number	AVFM08040
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On b)(6) 2026, a patient underwent a stent placement procedure using a covera vascular covered stent.During the procedure, while the delivery system was being withdrawn following stent deployment, the stent migrated distally by approximately 6 cm.To secure the migrated stent, an additional stent was deployed.It was further reported that the patient has a functioning shunt and is being closely monitored to assess continued access patency and stent stability.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.In this case the stent was intended to be placed in an av graft, not particular difficult anatomy was reported.Choosing the correct stent diameter is determined to be a significant factor to prevent stent migration.The information provided in this case do not indicate that the diameter of used covered stent was too small.The tip getting snagged on the placed covered stent might be another potential cause.However, as the delivery system was not available for evaluation and no images were provided, a potential device issue 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 instructions for use (ifu) states that covered stent specific events 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 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." h.4.Device manufacture date: unknown.B5, g3, h6 (method) 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 25762528
• Report Number: 9681442-2026-00150
• Device Sequence Number: 13196678
• Product Code: PFV
• UDI-Device Identifier: 00801741106507
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: AVFM08040
• Device Lot Number: ANKZ2086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/22/2026
• 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