MAUDE Adverse Event Report: Angiomed GmbH & Co. Medizintechnik KG Venovo Venous Stent

Catalog Number	VENUM14120
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
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 returned sample is in used condition with activated deployment mechanism, and the stent is loaded without tip to sheath gap.Inside grip, the force transmitting adhesive joint of the slide block is loose which made a stent deployment impossible.In this case only limited information was provided.Based on the investigation of the provided information, the investigation is closed as confirmed for failure of an adhesive joint inside grip and subsequent deployment 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.Holding and handling of the system throughout deployment as found sufficiently described.The instructions for use (ifu) state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' and 'predilation of chronic lesions with a balloon dilatation catheter is recommended'.Regarding accessories the ifu state: '(.) 8f introducer for stent diameters of 10 mm and 12 mm - 9f introducer for a stent diameter of 14 mm - 10f introducer for stent diameters of 16 mm, 18 mm and 20 mm - 0.035 inch diameter guidewire (.)'.Section a through f: the information provided by bd represents all of 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) 2026, a patient underwent a stent placement procedure using a venovo venous stent in the iliac vein via femoral access.During the procedure, it was reported that the stent failed to deploy as intended.The procedure was subsequently completed using another venovo venous stent.The patient was reported to be in good condition, and there was no reported patient injury.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50850444
• Report Number: 9681442-2026-00221
• Device Sequence Number: 18648280
• Product Code: QAN
• UDI-Device Identifier: 00801741103452
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2026

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: VENUM14120
• Device Lot Number: ANJX1800
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/22/2026
• 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 Sex: Unknown