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

Catalog Number	VENUM16160
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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 return of the sample is pending.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, the stent was allegedly deployed after delayed.It was further reported distal was slightly foreshorten.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure, the stent was allegedly deployed after delayed.It was further reported distal was slightly foreshorten.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.Investigation summary: the delivery system was not returned for evaluation, the stent remains implanted.No photos or x-rays were provided.It is unknown, whether an introducer sheath was used.No difficult anatomy was reported.As the delivery system was not returned for evaluation, a potential device relation of the reported issue could not be verified.Based on information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.The information for use (ifu) was found to address potential complications and adverse events which may occur during use of the venovo venous stent system, e.G., incorrect positioning of the stent requiring further stenting or surgery or malposition (failure to deliver the stent to the intended site).The stent deployment procedure is described in the ifu.In particular the ifu states: "any slack in the stent system (outside the patient) could result in deploying the stent beyond the target site." and "do not hold or touch the dark moving sheath during stent release.(.) 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.¿ regarding accessories and access for the delivery system the ifu states: "gain femoral, popliteal or jugular access utilizing an appropriate introducer sheath." g3, h6 (method, 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
On (b)(6) 2025 a patient underwent the stent placement procedure.It was reported that during a procedure; the stent was allegedly deployed after delayed.It was further reported distal was slightly foreshorten.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.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 but functional condition without stent that reportedly has been deployed inside patient.During evaluation testing wheel activation leads to prompt reaction of the deployment mechanism at low force level, and a damage potentially indicating difficult deployment or irregular stent deployment cannot be found.Images demonstrating the deployed stent were not provided.The investigation leads to inconclusive result.A manufacturing related issue could not be found.In this case it is unknown, whether an introducer sheath was used.A 0.035" guidewire was used for deployment, the lesion was pre dilated, and no difficult anatomy was reported.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labelling review: relevant labeling supplied with this product was reviewed.The instructions for use (ifu) was found to address potential complications and adverse events which may occur during use of the venovo venous stent system e.G., incorrect positioning of the stent requiring further stenting or surgery or malposition (failure to deliver the stent to the intended site).The stent deployment procedure is described in the ifu.In particular the ifu states: "any slack in the stent system (outside the patient) could result in deploying the stent beyond the target site." and "do not hold or touch the dark moving sheath during stent release.(.) 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." regarding accessories and access for the delivery system the ifu states: "gain femoral, popliteal or jugular access utilizing an appropriate introducer sheath.(.) insert a guidewire of appropriate length (table 3) and 0.035 inch diameter (.).Under required material the ifu state "10f introducer for stent diameters of 16 mm, 18 mm and 20 mm".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.

• 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: 21796884
• Report Number: 9681442-2025-00119
• Device Sequence Number: 15388697
• Product Code: QAN
• UDI-Device Identifier: 00801741103612
• UDI-Public: (01)00801741103612(17)260606(10)ANJT0843
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 08/22/2025

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 Expiration Date: 06/06/2026
• Device Catalogue Number: VENUM16160
• Device Lot Number: ANJT0843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 08/22/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 07/16/2025; 08/28/2025
• 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 Sex: Unknown