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

Catalog Number	AVFM10060
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f ¿ the information provided 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 graft placement procedure using covera vascular covered stent.During the procedure covera stent was deployed in a fistula.It was reported that, the stent seemed to fully deploy but allegedly failed to release from the delivery system.It was further reported that the stent was removed forcefully from the patient.Reportedly, the patient experienced pain during removal of device.The procedure was completed using another device.The current status of the patient 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.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 returned for evaluation with the covered stent completely deployed and missing.There were no signs of damage on the device depicting failure to deploy or difficulty in removing the device from the patient which leads to inconclusive results.There were no indications of manufacturing deficiencies.In this case, it was reported that the lesion was pre-dilated.Based on information available and the evaluation of the returned sample, the investigation is closed with inconclusive results.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) material required for a procedure using the covera vascular covered stent are (.) 0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter.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." the ifu states "carefully remove the delivery system under fluoroscopy while maintaining guidewire access".G3, h6 (component, result, conclusion) section a through f ¿ the information provided 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 graft placement procedure using covera vascular covered stent.During the procedure, covera stent was deployed in a fistula.It was reported that; the stent seemed to fully deploy but allegedly failed to release from the delivery system.It was further reported that the stent was removed forcefully from the patient.Reportedly, the patient experienced pain during removal of device.The procedure was completed using another device.The current status of the patient was unknown.

• 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: 23252709
• Report Number: 9681442-2025-00329
• Device Sequence Number: 10236360
• Product Code: PFV
• UDI-Device Identifier: 00801741106590
• UDI-Public: (01)00801741106590(17)270123(10)ANKN2825
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AVFM10060
• Device Lot Number: ANKN2825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown