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

Model Number VENUM14140

Device Problems Difficult or Delayed Positioning (1157); Activation Failure (3270)

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

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 12/2022).

Event Description

It was reported that during stent placement procedure through bilateral pop, the stent allegedly had expansion issue.It was further reported that the stent allegedly was difficult to deploy.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot history record of this lot was 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 physical sample was not available.Image provided demonstrating an hour-glass like deformation of the stent in the area of the stent brake confirmed that the stent adhered to the inner catheter stent brake during deployment which leads to a confirmed investigation result for expansion issue.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 complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: d4 (expiry date: 12/2022), g3 h11: h6 (component, method, result) 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 : device not returned.

Event Description

It was reported that during stent placement procedure through bilateral pop, the stent allegedly had expansion issue.It was further reported that the stent allegedly was difficult to deploy.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
• MDR Report Key: 11479808
• MDR Text Key: 253196877
• Report Number: 9681442-2021-00144
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103469
• UDI-Public: (01)00801741103469
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: ANEZ1475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other