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

Catalog Number	AVFM10080
Medical Device Problem Codes	Material Deformation (2976); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a stent placement surgery procedure using covera vascular covered stent about 1 month ago.During follow-up it was found that the post declot and access was hyper pulsatile and inside the stent is another crushed stent that is crushed.The current status of patient is unknown.
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) 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.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.
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: it was reported that a 10x80 mm stent (ankn1659) was placed in (b)(6) 2025 inside two stents that were found with a line, respectively a flap.A 10x60 mm stent was placed in (b)(6) 2024 one month after a declot procedure was performed.During a follow-up in (b)(6) 2024 it was found that the stent was narrowing and the access was hyper pulsatile; the stent was alleged to be crushed.The placed stent was extended proximally with another 10x60mm stent.Based on the information provided, there is no indication that there was any alleged device deficiency regarding the third stent and an investigation regarding this sent is not required.Investigation of an alleged device deficiency for the first and second stent is referenced in a related complaint record.Labeling review: based on the information provided, there is no indication that there was any alleged device deficiency regarding this third stent.Therefore, review of the labeling of the device covera vascular covered stent is not required.G3, h6 (device, component, method, result, conclusion) 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
A patient underwent a stent placement surgery procedure using covera vascular covered stent about 1 month ago.During follow-up it was found that the post declot and access was hyper pulsatile and inside the stent is another crushed stent that is crushed.The current status of patient is unknown.
Event or Problem Description
A patient underwent a stent placement procedure using covera vascular covered stent about a month ago.Post the procedure, during follow-up it was found that the post declot and access was hyper pulsatile and inside the stent is another crushed stent that is crushed.The current status of 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: it was reported that a 10x80 mm stent (ankn1659) was placed in (b)(6) 2025 inside two stents that were found with a line, respectively a flap.A 10x60 mm stent was placed in (b)(6) 2024 one month after a declot procedure was performed.During a follow-up in (b)(6) 2024 it was found that the stent was narrowing and the access was hyper pulsatile; the stent was alleged to be crushed.The placed stent was extended proximally with another 10x60mm stent.Based on the information provided, there is no indication that there was any alleged device deficiency regarding the third stent and an investigation regarding this sent is not required.Investigation of an alleged device deficiency for the first and second stent is referenced in a related complaint record.Labeling review: based on the information provided, there is no indication that there was any alleged device deficiency regarding this third stent.Therefore, review of the labeling of the device covera vascular covered stent is not required.B5, g3.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: 22893129
• Report Number: 9681442-2025-00269
• Device Sequence Number: 14910061
• Product Code: PFV
• UDI-Device Identifier: 00801741106606
• UDI-Public: (01)00801741106606(17)270116(10)ANKN1659
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,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: AVFM10080
• Device Lot Number: ANKN1659
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 11/11/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/06/2025; 11/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown