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

Catalog Number	AVSM10060
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
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 sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 during a stent graft placement procedure, the stent allegedly folded on itself.It was further reported that the stent was allegedly crushed.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: no specific lot# was provided, therefore, no dhr-review could be performed.Investigation summary: the delivery system or the stent were not returned for evaluation and photos were not provided which leads to inconclusive results.Based on information available and as neither sample nor photos were provided for evaluation, the investigation is closed with inconclusive results for stent deformation.A definite root cause for the reported issue could not be identified.Labeling review: current version of instruction for use (ifu) supplied with this product: (eifu covera vascular covered stent us).Relevant labeling for this product was reviewed.Potential complications and adverse events were found to be referenced.The 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; 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 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." h10: g3.H11: h6 (patient, method).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 during a stent graft placement procedure, the stent allegedly folded on itself.It was further reported that the stent was allegedly crushed.The procedure was completed using another device.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: the delivery system was not returned, and the stent remains implanted.Two pdf files with multiple x-ray images were provided.Based on the pdf files it is reasonably suggested that the stent was placed on (b)(6) 2024, in an av graft of the left upper arm, a significate deformation of the stent was found on images labeled with (b)(6) 2024.These images show dilation of the stent using a balloon catheter and placement of an additional stent with post dilation.However, both stents remain deformed.In this case, limited information was provided by the customer.Based on x-ray images provided, an indication for a device related issue causing the stent to collapse could not be determined.Based on information available and evaluation of the provided images, the investigation is closed with confirmed results for material deformation.Based on x-ray images provided, an indication for a device related issue causing the stent to collapse could not be determined.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, 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 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." d4 (medical device lot #, medical device expiration date, unique identifier (udi) #), g3, h6 (method, result) 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
It was reported that during a stent graft placement procedure, the stent allegedly folded on itself.It was further reported that the stent was allegedly crushed.The procedure was completed using another device.There was no reported patient injury.

• 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: 21511005
• Report Number: 9681442-2025-00050
• Device Sequence Number: 4591497
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392(17)260411(10)ANJR1582
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/14/2025

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: 04/11/2026
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANJR1582
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 05/30/2025; 07/10/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/25/2025
• 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 Sex: Unknown