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

Catalog Number VENEM16160

Device Problems Positioning Failure (1158); Activation Failure (3270)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

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.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.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2024).

Event Description

It was reported that during a stent placement procedure in the iliac vein, the proximal part of the stent allegedly could not be expanded from the inner catheter.It was further reported that further a strut still remained stuck to the inner catheter, after full expansion.Reportedly, the stent could be detached after several jerky movements.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 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: 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 returned for evaluation; the stent brake of the inner catheter which is under the stent was found with significant imprints and damage on its surface; this is considered an indication that the stent adhered to the stent brake immediately after deployment.Also, one provided x-ray video demonstrates the proximal end of the deployed stent adhering to the inner catheter in the area of the stent cushion.The user is moving the guidewire which leads to final and complete expansion of the stent.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.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 requiring further stenting or surgery, intimal injury, stent fracture, and misplacement.H10: d4 (expiry date: 08/2024), g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : see h10.

Event Description

It was reported that during a stent placement procedure in the iliac vein, the proximal part of the stent allegedly could not be expanded from the inner catheter.It was further reported that further a strut still remained stuck to the inner catheter, after full expansion.Reportedly, the stent could be detached after several jerky movements.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: 16824104
• MDR Text Key: 314110180
• Report Number: 9681442-2023-00166
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741102424
• UDI-Public: (01)00801741102424
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/30/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: VENEM16160
• Device Lot Number: ANGV3140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/03/2023
• 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