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

Catalog Number VENEM16120

Device Problem Activation Failure (3270)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified in d2 and g4.H10: a voluntary recall has been initiated for the venovo¿ venous stent system 10f 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: the lot history records of this lot# were reviewed with special attention to the manufacturing and inspection of this 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 issues.Investigation summary: the physical sample was not available for evaluation.Provided image/ movie demonstrate complete deployment of the stent inside vessel, and the stent visibly adheres to the inner catheter stent cushion whereas distal and proximal to that section the stent is expanded.The investigation leads to confirmed result for stent expansion issue.Based on the investigation of the provided information, the investigation is closed as confirmed for stent expansion issue.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, injury, stent fracture, and misplacement.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.H3 other text : device not returned.

Event Description

It was reported that during a stent graft placement procedure, the stent allegedly did not open fully.It was further reported that the distal end of the stent allegedly seemed to be stuck to the delivery rod and could not be completely freed.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified in d2 and g4.H10: a voluntary recall has been initiated for the venovo¿ venous stent system 10f 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: the lot history records of this lot# were reviewed with special attention to the manufacturing and inspection of this 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 issues.Investigation summary: the physical sample was not available for evaluation.Provided image/ movie demonstrate complete deployment of the stent inside vessel, and the stent visibly adheres to the inner catheter stent cushion whereas distal and proximal to that section the stent is expanded.The investigation leads to confirmed result for stent expansion issue.Based on the investigation of the provided information, the investigation is closed as confirmed for stent expansion issue.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, injury, stent fracture, and misplacement.H10: b5, d4 (expiration date: 09/2024), g3 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.H3 other text : device not returned.

Event Description

It was reported that during a stent graft placement procedure in the iliac vein via transverse approach, the stent allegedly did not open fully.It was further reported that the distal end of the stent allegedly seemed to be stuck to the delivery rod and could not be completely freed.Reportedly, the large and small rollers on the release handle were rolled back and forth to release the stent, and the delivery rod was rotated to detach the stent from the catheter.There was no reported patient injury.

• 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: 18683893
• MDR Text Key: 335073827
• Report Number: 9681442-2024-00017
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741102400
• UDI-Public: (01)00801741102400
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VENEM16120
• Device Lot Number: ANGW0052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• 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