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); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: 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
It was reported that during a stent placement procedure in the left iliac vein via left femoral vein, the stent was allegedly stopped deployed midway through.It was further reported that physician allegedly had to open up deployment handle and deploy manually.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 without stent that reportedly has been deployed inside patient.Inside grip, a force transmitting adhesive joint is broken which made a successful deployment using the grip impossible.Therefore, the investigation leads to confirmed result for break of a force transmitting adhesive joint.Images demonstrating the partially deployed stent were not provided, but based on provided information, and condition of the returned sample it was assessed to be likely that the user could only partially deploy the stent.A manufacturing related issue could not be found.In this case system compatible 0.035" guidewire with 10fx10cm introducer were used for access, the vessel was not tortuous, the lesion was pre dilated, and the system was correctly held at the stability sheath during deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for break of a force transmitting adhesive joint inside grip and partial stent deployment.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 instructions for use (ifu) state: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' holding and handling of the system throughout deployment was found described, in particular the ifu state: 'hold stability sheath.Do not hold or touch the dark moving sheath.' regarding pta the ifu states: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.' under required material the ifu states: '9f introducer for a stent diameter of 14 mm (.) 0.035 inch diameter guidewire.' g3, h3, h6 (device, component, result, conclusion) 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
It was reported that during a stent placement procedure in the left iliac vein via left femoral vein, the stent was allegedly stopped deployed midway through.It was further reported that physician allegedly had to open up deployment handle and deploy manually.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21729067
• Report Number: 9681442-2025-00104
• Device Sequence Number: 4196991
• Product Code: QAN
• UDI-Device Identifier: 00801741103452
• UDI-Public: (01)00801741103452(17)261010(10)ANJX1800
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Unknown
• Patient Race: White