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

Catalog Number	VENUM14080
Medical Device Problem Codes	Break (1069); Fracture (1260); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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) 2024, a patient underwent a stent placement procedure using a venovo venous stent.In (b)(6) 2024, a scout scan and ct allegedly identified a stent fracture at the level of the initial stenosis and noticed a watermelon seed type migration towards the right atrium.Patient presented to the hospital with a cystic fibrosis exacerbation and had a chest x-ray performed.The stent was observed to have a large fracture.A chest ct was performed to visualize the fracture.Current plan is to try and retrieve the stent via ij access and pull the stent off the wall and up to the ij.Cv surgery will assist to provide a vessel cut down to retrieve the stent.If unsuccessful cv surgery will retrieve via open chest.According to reports, the patient experienced an exacerbation of cystic fibrosis.To remove the fractured stent, vessel cut-down surgery was performed.
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, no specific lot was provided, therefore, no dhr-review could be performed.Investigation summary: neither sample nor images provided which leads to inconclusive results.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.Deployment of the stent in the vena cava for rebuild represents an off-label use.Labelling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Regarding pta the instructions for use (ifu) state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.', and 'post stent expansion with a balloon dilatation catheter is recommended.' under required material the ifu state 9f introducer for a stent diameter of 14 mm and 0.035 inch diameter guidewire.The ifu further state: 'if a long lesion needs to be stented consider using the longest available stent rather than overlapping stents.' stent fracture is mentioned a potential complication/ adverse event.A stent size selection table is part of the ifu describing the relationship between vessel diameter and stent diameter.Holding and handling of the system for regular deployment was found described.The venovo venous stent system is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.G3, h6 (device, 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.
Event or Problem Description
On (b)(6) 2024, a patient underwent a stent placement procedure using a venovo venous stent.In (b)(6) 2024, a scout scan and ct allegedly identified a stent fracture at the level of the initial stenosis and noticed a watermelon seed type migration towards the right atrium.Patient presented to the hospital with a cystic fibrosis exacerbation and had a chest x-ray performed.The stent was observed to have a large fracture.A chest ct was performed to visualize the fracture.Current plan is to try and retrieve the stent via ij access and pull the stent off the wall and up to the ij.Cv surgery will assist to provide a vessel cut down to retrieve the stent.If unsuccessful cv surgery will retrieve via open chest.According to reports, the patient experienced an exacerbation of cystic fibrosis.To remove the fractured stent, vessel cut-down surgery was performed.

• 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: 22318404
• Report Number: 9681442-2025-00189
• Device Sequence Number: 8858015
• Product Code: QAN
• UDI-Device Identifier: 00801741103438
• UDI-Public: (01)00801741103438
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VENUM14080
• Device Lot Number: UNKNOWN
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown