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

Model Number VENUM18160

Device Problems Misfire (2532); Material Deformation (2976); Activation Failure (3270)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022); device not returned.

Event Description

It was reported that during a stent placement through iliac vein, the device allegedly failed to expand.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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.Investigation summary: the delivery system was not returned for evaluation.Provided images demonstrate an elongated and narrowed stent inside the vessel.Images directly after deployment were not provided so that neither a deployment issue nor an expansion issue could be confirmed.The provided images lead to a confirmed result for stent elongation although this was considered a cascading event after the alleged expansion issue.The investigation is confirmed for stent elongation.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant for this product was conducted.The ifu was found to address potential complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: d4 (expiry date: 08/2022), g4 h11: h6 (results, conclusion) h11: section a through f ¿ the information provide 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.Device not returned.

Event Description

It was reported that during a stent placement in the iliac vein through femoral access, the stent allegedly was stuck on the delivery system and failed to expand.It was further reported that an additional stent was placed because the stent collapsed again.There was no reported patient injury.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Type of Device: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11009853
• MDR Text Key: 221541205
• Report Number: 9681442-2020-20084
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103759
• UDI-Public: (01)00801741103759
• Combination Product (y/n): N
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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 Model Number: VENUM18160
• Device Catalogue Number: VENUM18160
• Device Lot Number: ANEV0612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other