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

Catalog Number	AVSM08040
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
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 will 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) are 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.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 the covera vascular covered stent via basilic vein.The stent prematurely exited the delivery sheath when it was approximately halfway deployed.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 sample was returned for evaluation and the safety slider was unlocked and the covered stent was completely deployed and missing as it was placed in the patient.The inner catheter was protruding the tip and the pushing was out of the sheath.X-ray images have not been provided and therefore it is not possible to determine the position of the placed stent which leads to inconclusive results.There were no indication of manufacturing deficiency.In this case, it was reported that an 8f introducer and a 0.035" guidewire were used for access, the tracking vessel was neither tortuous nor calcified, the lesion was pre-dilated and the device was flushed before use.X-ray images have not been provided and therefore it is not possible to determine the position of the placed stent.Based on information available and the evaluation of the returned sample, the reported issue could not be verified and the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use (ifu) closely describes holding and handling of the system throughout deployment.In particular the ifu state: "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".The ifu further state: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated".Regarding accessories, the ifu indicates "0.035 inch guidewire of appropriate length to allow safe delivery of the covered stent and removal of the delivery system and an introducer sheath with appropriate inner diameter".The ifu states that "special care must be taken to ensure that an appropriately sized device is selected"; a stent size selection table is part of the ifu describing the relationship between reference vessel diameter and covered stent diameter.Covered 'stent misplacement' and migration were found mentioned as potential clinical complications that could be associated with the use of this product.D4 (medical device catalog #, medical device lot #, medical device expiration date, unique identifier (udi) #), 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure using the covera vascular covered stent via basilic vein.The stent prematurely exited the delivery sheath when it was approximately halfway deployed.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: 22901498
• Report Number: 9681442-2025-00275
• Device Sequence Number: 12994738
• Product Code: PFV
• UDI-Device Identifier: 00801741106286
• UDI-Public: (01)00801741106286(17)260920(10)ANJW2364
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/15/2025

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: 09/20/2026
• Device Catalogue Number: AVSM08040
• Device Lot Number: ANJW2364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White