MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT

Catalog Number	VENUM14140
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
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 is completed.The device is not available for return to the manufacturer for evaluation.However, images were provided for review.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 placement procedure using venovo venous stent device.During procedure, the device allegedly had malfunction.There was no reported patient injury.
Event or Problem Description
A patient underwent a stent placement procedure using venovo venous stent device.During procedure, the device allegedly had malfunction.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 catheter sample is not available for evaluation.Two provided x-ray images demonstrate the placed stent inside the vessel.The images demonstrate the same view; on one image a clear dent is visible which is significantly reduced on the other image.It is assumed that the image with a slight dent was taken after post pta.Additional views of the irregular section were not provided so that a more detailed description of the deformation is not possible.The investigation leads to confirmed result for stent deformation.In this case only limited information was provided.A manufacturing related root cause was considered; therefore, the lot history records 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.Based on the information available a definite root cause could not be identified.Based on the investigation of the provided information, the investigation is closed as confirmed for stent deformation.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 ifu describes holding and handling of the system throughout the procedure.Regarding pta the ifu state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.', and 'post stent expansion with a balloon dilatation catheter is recommended.' a stent size selection table is part of the ifu describing the relationship between stent diameter and vessel diameter.B5, g3, h6 (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.

• Brand Name: VENOVO VENOUS STENT
• Common Device Name: VENOUS 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: 23641940
• Report Number: 9681442-2025-00386
• Device Sequence Number: 13226320
• Product Code: QAN
• UDI-Device Identifier: 00801741103469
• UDI-Public: (01)00801741103469(17)270513(10)ANKS1279
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• 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): 01/22/2026

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 Catalogue Number: VENUM14140
• Device Lot Number: ANKS1279
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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