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

Model Number VENUM14160

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

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

Event Date 11/19/2020

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, image was provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that during a stent placement, the device allegedly had difficulty to deploy and failed to expand in the distal part.There was no reported patient injury.

Manufacturer Narrative

H10: 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 sample was returned for evaluation.The condition of the returned delivery system confirmed the alleged expansion issue.The silicone brake of the inner catheter, which was under the stent, was found shifted to distal which indicated that the stent adhered to the brake leading to breakaway and shifting upon removal.One image was provided demonstrating the placed stent inside the vessel.The stent was visibly constricted in the area of the silicone stent brake.Distal and proximal of that section the stent was regularly expanded so that it appeared like an hour-glass which indicated that the deployment sheath was retracted and that the stent adhered to the silicone brake, which leads to a confirmed result for expansion issue.A definite root cause for the reported event could not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 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), g3 h11: h6 (method, result) 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.See h10.

Event Description

It was reported that during a stent placement, the device allegedly had difficulty to deploy and failed to expand in the distal part.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: 11017481
• MDR Text Key: 226228982
• Report Number: 9681442-2020-20090
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103476
• UDI-Public: (01)00801741103476
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUM14160
• Device Catalogue Number: VENUM14160
• Device Lot Number: ANEV3085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other