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

Catalog Number	VENUM16060
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2026
Type of Reportable Event	Malfunction
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.A manufacturing related root cause was considered.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.Investigational summary: the returned sample is in locked condition with fully/ correctly loaded stent.A kink is present in the mid section of the catheter system.During device testing, the guidewire can be easily inserted and advanced from both ends until the kinked section is reached when the guidewire gets stuck.The investigation confirms kink leading to failure to advance.A process related issue could not be found.Based on the investigation of the provided information, the investigation is closed as confirmed for catheter kink and failure to advance.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 state: 'prior to use flush the guidewire lumen of the stent system with normal, sterile saline until saline exits the tip of the system', and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.' under required materials the ifu state a 0.035" guidewire.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
On (b)(6) 2026, a patient underwent a stent placement procedure using venovo stent via right femoral vein.Prior to the procedure, the stent could not be advanced over the guidewire.The procedure was completed using another device.There was no patient contact.

• 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: 50767711
• Report Number: 9681442-2026-00215
• Device Sequence Number: 18497900
• Product Code: QAN
• UDI-Device Identifier: 00801741103568
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/11/2026

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: VENUM16060
• Device Lot Number: ANKZ1102
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/15/2026
• 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