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

Model Number VENUM14140

Device Problems Material Fragmentation (1261); Material Deformation (2976); Activation Failure (3270)

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

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.Device pending return.

Event Description

It was reported that during a stent placement procedure, the stent allegedly sticking and catching at deployment.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure in the frontal femoral through iliac access, the stent allegedly sticking and catching at deployment.It was further reported that the catheter allegedly kinked during the removal from the patient causing the difficulty in removing the delivery system through the introducer sheath.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: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was returned for evaluation.The condition of the returned delivery system confirms stent expansion issue.The stent cushion of the inner catheter which is under the stent during deployment was found shifted to distal direction with fragmental damage on its surface which is considered an indication that the stent adhered to the stent cushion immediately after deployment.It is also confirmed that the system was kinked.A detailed description of the expansion behavior of the stent over time to complete expansion is not possible based on investigation of the returned device.Based on the information available the investigation is closed with confirmed result.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instructions for use for this product was conducted.The instructions 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 requiring further stenting or surgery, intimal injury, stent fracture, and malposition.The instructions for use further states: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' 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.

• 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: 16331500
• MDR Text Key: 309272544
• Report Number: 9681442-2023-00022
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103469
• UDI-Public: (01)00801741103469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUM14140
• Device Catalogue Number: VENUM14140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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