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

Model Number VENUM20080

Device Problems Difficult or Delayed Activation (2577); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

H10: a voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent that are cleared in the us.The pro code and 510 k number for the venovo venous stent are identified in d2 and g4.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, videos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2024).H11: section a through f ¿ the information provided 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 Description

It was reported that during a stent placement procedure in superior vena cava via right brachial vein access, the proximal end of the stent allegedly failed to expand upon deployment.The procedure was completed using same device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure in superior vena cava via right brachial vein access, the proximal end of the stent allegedly failed to expand upon deployment; high deployment force was felt, and the user waited about thirty seconds when the stent finally expanded from the system.The procedure was completed using same device.There was no reported patient injury.

Manufacturer Narrative

H10: a voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent that are cleared in the us.The pro code and 510 k number for the venovo venous stent are identified in d2 and g4.H10: manufacturing review: 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.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 sample was not available for evaluation.Provided x-ray videos demonstrate complete deployment of the stent, and the stent is adhering to inner catheter immediately after deployment, which leads to confirmed result for stent expansion issue.However, the video also confirms complete expansion without need of any accessories.Based on the videos an evaluation for high resistance during deployment was not possible.Based on the information available the investigation is closed with confirmed result for stent expansion issue.A definite root cause for the reported event could not be determined.Placement in the vena cava represents an off label use.Labeling review: a review of the relevant instruction for use for this product was conducted.The instruction for use was found to address potential worst case complications and adverse events potentially related to expansion issue such as incorrect positioning of the stent, stent fracture, malposition, and surgical intervention.Regarding high deployment force the instruction for use states: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit'.The venovo venous stent system is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.H10: b5, d4 (expiry date: 09/2024), g3, h6 (device).H11: h6 (method, result, conclusion).H11: section a through f ¿ the information provided 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.

• Brand Name: VENOVO VENOUS STENT
• Type of Device: 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: 16884147
• MDR Text Key: 314716198
• Report Number: 9681442-2023-00172
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103858
• UDI-Public: (01)00801741103858
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUM20080
• Device Catalogue Number: VENEM20080
• Device Lot Number: ANGW3298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1897-2021
• Patient Sequence Number: 1