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

Catalog Number	VENUM12080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
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 not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H11: 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 stent placement procedure.It was reported that during follow-up visit on (b)(6) 2025, the stent was allegedly fractured.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: h10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.H10: g3.H11: b1, b5, e1, h1, h6 (patient).H11: 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 39-year-old female patient underwent a stent placement procedure for the complete occlusion of superior vena cava, stenting of right subclavian vein to superior vena cava to 12mm via right upper extremity graft site using venovo venous stent.Sometime post a stent placement, the patient arm/neck right side allegedly swelled and the stent allegedly fractured.The patient is awaiting re-treatment.
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 catheter sample is not available for evaluation.Provided image demonstrates the placed stent inside a vessel curve, and the stent is fractured in two sections.One fracture in the curved section (multiple strut fracture), and a second fracture towards the end of the stent which is a complete transversal fracture with axial disposition.A manufacturing related issue could not be found.Based on the investigation of the provided information, the investigation is closed as confirmed for stent fracture.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 instruction for use closely describes holding and handling of the system for regular deployment.Regarding pta the instruction for use state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.', and 'post stent expansion with a balloon dilatation catheter is recommended.' regarding access/ accessories the ifu state: 'gain femoral, popliteal or jugular access utilizing an appropriate introducer sheath.' under required materials the instruction for use state: '8f introducer for stent diameters of 10 mm and 12 mm (.) 0.035 inch diameter guidewire' based on the ifu, stent fracture is a potential adverse event that may occur.The venovo venous stent system is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.H10: g3.H11: h6(method, result, conclusion).H11: 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 39 year old female patient underwent a stent placement procedure for the complete occlusion of superior vena cava, stenting of right subclavian vein to superior vena cava to 12mm via right upper extremity graft site using venovo venous stent.Sometime post a stent placement, the patient arm/neck right side allegedly swelled and the stent allegedly fractured.The patient is awaiting re-treatment.

• 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: 21965700
• Report Number: 9681442-2025-00150
• Device Sequence Number: 12790136
• Product Code: QAN
• UDI-Device Identifier: 00801741103292
• UDI-Public: (01)00801741103292(17)260430(10)ANJR4209
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: VENUM12080
• Device Lot Number: ANJR4209
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 05/27/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/22/2025; 05/29/2025
• 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 Age: 39 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: Native Hawaiian Or Other Pacific Islander