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

Catalog Number	AVSM10040
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient's fistula was found clotted in less than one month after placement of the stent.It was identified that the peripheral end of stent was collapsed and it was extremely difficult to pass the wire into central veins.Angioplasty was performed of the collapsed stent using a 10mm angioplasty balloon to straightened the stent.Another brand stent was placed with good result on both angiogram and physical examination.The patient¿s fistula is working well during dialysis.
Additional Manufacturer Narrative
H11: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was not returned for evaluation, the stent remains implanted.Based on x-ray images provided collapse of the distal end of the stent is confirmed.Based on information available, collapse of the distal end of the stent is confirmed.However, no damage or structural defects of the stent can be identified.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling for this product was reviewed.Potential complications and adverse events were found to be referenced.The instructions 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 covered stent deployment were found to be described in the instructions for use, e.G., "maintain a stationary hold on the white stability sheath during covered stent deployment (¿).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension.Regarding choosing the size of the covered stent, the instructions 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." 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22456872
• Report Number: 9681442-2025-00210
• Device Sequence Number: 18215559
• Product Code: PFV
• UDI-Device Identifier: 00801741106385
• UDI-Public: (01)00801741106385(17)260223(10)ANJP3186
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 06/19/2025

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 Expiration Date: 02/23/2026
• Device Catalogue Number: AVSM10040
• Device Lot Number: ANJP3186
• 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: 06/13/2025
• Initial Report FDA Received Date: 07/09/2025
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: Black Or African American