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); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: manufacturing review: the lot history records 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 catheter sample is in used condition with unlocked safety slider.The stent is shifted to distal inside the stent sheath, and the force transmitting adhesive joint between slide block and proximal catheter is separated which made a successful deployment impossible.Residuals of cured adhesive are clearly visible in the joint section.The investigation leads to confirmed result for failure of an adhesive joint and failure to deploy.A manufacturing related issue could not be found.In this case 10fx45cm introducer with 0.035 guidewire were used for access, the lesion was pre-dilated, and it was difficult to get through the stenosis.A manufacturing related root cause was considered.Based on the information available a definite root cause could not be identified.Based on the investigation of the provided information, the investigation is closed as confirmed for loss of an adhesive joint and subsequent deployment failure.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: 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.Under required materials the ifu state: 8f introducer for stent diameters of 10 mm and 12 mm, 9f introducer for a stent diameter of 14 mm, 10f introducer for stent diameters of 16 mm, 18 mm and 20 mm, 0.035 inch diameter guidewire.The ifu further state: predilation of chronic lesions with a balloon dilatation catheter is recommended.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), 2026, a patient underwent stent placement procedure using venovo stent for iliac vein thrombosis.It was reported that the stent failed to deploy.The procedure was completed using another device.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: 25562881
• Report Number: 9681442-2026-00127
• Device Sequence Number: 10012974
• Product Code: QAN
• UDI-Device Identifier: 00801741103452
• UDI-Public: (01)00801741103452(17)261010(10)ANJX1800
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/15/2026

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: VENUM14120
• Device Lot Number: ANJX1800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/19/2026
• 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