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

Catalog Number	AVFM10100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Reduced Blood Flow (4598)
Date of Event	06/25/2026
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.On (b)(6) 2026, one week after implantation, it was reported that the stent became crushed.Due to the reported stent deformation, the patient became symptomatic and required implantation of an additional stent to maintain vessel patency.The patient's current condition was unknown.
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.The lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product lot and the products were found to have met the specification prior to shipment.Investigation summary: two image files were provided for evaluation, consisting of photographs of fluoroscopic images displayed on a monitor.Contrast media visible suggests an obstruction of blood flow inside the stent.However, due to the limited image quality and resolution, the structure and condition of the implanted covered stent could not be adequately assessed.No definitive conclusions could be drawn regarding the presence of stent deformation, damage, or insufficient device performance.The alleged issue of the covered stent becoming crushed one week after implantation could not be verified.Based on the information available, the investigation is closed with as inconclusive.Although the implanted covered stent was reported to be crushed approximately one week after placement and required reintervention with implantation of a secondary stent graft, the alleged deformation could not be verified through review of the provided imaging.Consequently, a definitive root cause for the reported event could not be determined.Labeling review: relevant product labeling and instructions for use (instruction for use) were reviewed.Potential complications and adverse events associated with covered stent implantation were found to be adequately addressed.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 other clinically relevant adverse events.The instruction for use also identifies covered stent-specific complications that may be associated with clinical outcomes, including misplacement, migration, embolization, fracture, compression, kinking, and insufficient stent expansion.Instructions for proper device preparation, sizing, and deployment are provided within the labeling.Regarding device sizing, 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 (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
• 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: 25867847
• Report Number: 9681442-2026-00157
• Device Sequence Number: 10585724
• Product Code: PFV
• UDI-Device Identifier: 00801741106613
• UDI-Public: (01)00801741106613(17)280126(10)ANLN2797
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AVFM10100
• Device Lot Number: ANLN2797
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 07/19/2026
• Supplement Report FDA Received Date: 09/07/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown