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

Catalog Number	AVSM06100
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a 53-year-old male patient underwent a stent placement procedure using a covera vascular covered stent for the treatment of severe stenosis at the juxta-anastomotic region of a left radiocephalic arteriovenous fistula (avf) via the left radiocephalic access site.During the procedure, it was reported that the stent failed to deploy, as the sheath did not retract when the thumbwheel was rotated.It was further reported that the internal wire did not respond to thumbwheel manipulation.The device was successfully retrieved and different brand of stent used and deployed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
H11: h.4.Device manufacture date: unknown.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 stent delivery system sample was returned for evaluation and the covered stent was found still loaded in the delivery system; the force transmitting proximal sheath was broken inside grip which indicates high tensile forces were experienced during deployment.The bonding joint between tether and slide block was broken.It is considered the break of the proximal sheath led to the impossibility to deploy the stent which leads to confirmed results for break, bonding joint failure and deployment failure.A process related issue could not be found.In this case, it was reported that an 8f introducer was used with a 0.035" guidewire for access, the tracking vessel was neither tortuous nor calcified and the lesion was pre-dilated.Based on available information and the evaluation of the returned sample, the investigation is closed with confirmed results for the positioning failure, sheath break and bonding joint failure.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.Based on the instructions for use (ifu) supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the ifu states: "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." based on the ifu material required are "(.) 0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter".The labeling pictograms indicate the use of an 8f introducer.Regarding preparation the ifu states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated".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: 50726391
• Report Number: 9681442-2026-00210
• Device Sequence Number: 16098843
• Product Code: PFV
• UDI-Device Identifier: 00801741106217
• UDI-Public: (01)00801741106217(17)260913(10)ANJW1591
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 09/04/2026

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 Expiration Date: 09/13/2026
• Device Catalogue Number: AVSM06100
• Device Lot Number: ANJW1591
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/11/2026
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 150 LB
• Patient Race: Black Or African American