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

Model Number VENUL16160

Device Problems Misfire (2532); Material Deformation (2976)

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

Event Date 12/17/2020

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 device has been returned to the manufacturer for evaluation; however, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022).

Event Description

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

Event Description

It was reported that during a stent placement procedure in the iliac vein with ipsilateral femoral access, a wire was visible at the deployment wheel, and a force increase was felt, and the stent was allegedly partially deployed towards the stent end.Reportedly, final deployment was achieved by pulling on the wire.The procedure was completed using an additional device at the distal end of the stent.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 device was returned for evaluation.The provided image demonstrates stent strut irregularity inside the vessel towards the stent end which may be a consequence of the alleged partial stent deployment but the delivery system was not visible on the image.Although the returned system did not clearly indicate a partial stent deployment the condition of the sample, the user's detailed description, and the condition of the stent on the image were considered enough material to confirm a partial stent deployment.Partial deployment may be caused by the release cord getting caught inside the grip as reported.In this case system compatible introducer and guidewire were being used, but the lesion was not pre dilated.The patient anatomy was not difficult.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' in regards to pre dilation the instructions for use state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.' under materials required the instructions for use state '10f introducer for stent diameters of 16 mm, 18 mm and 20 mm (¿) 0.035 inch diameter guidewire.' in regards to damage the instructions for use state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.' the instructions for use further state: 'deployment of the stent is complete when the proximal stent radiopaque markers appose the vessel wall.' 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.

• 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: 11160939
• MDR Text Key: 226661558
• Report Number: 9681442-2020-20158
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103681
• UDI-Public: (01)00801741103681
• 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: 06/11/2021

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: VENUL16160
• Device Catalogue Number: VENUL16160
• Device Lot Number: ANEV2628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other