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

Model Number VENUM18080

Device Problems Positioning Failure (1158); Fracture (1260); Premature Activation (1484); Malposition of Device (2616); Activation Failure (3270)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.However, video was provided for review.Therefore, 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 procedure in the common and external iliac vein, the stent allegedly did not deploy.It was further reported that the stent deployed automatically and got deployed in the wrong vessel and ended up smashing it against the wall and onto another 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 physical sample was not available, one video clip provided demonstrates a released, deformed and partially opened stent in the femoral section including the deployment of the second stent securing the mispositioned stent against the vessel wall.Deployment action and withdrawal attempt is not visible on the video clip so that the video only demonstrates the consequences of the alleged deployment failure and withdrawal attempt; a strut fracture was not clearly visible.A detailed re construction of the deployment was not possible.Based on the information available the investigation is closed with confirmed result for malposition.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 states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' in regards to damage, the instructions for use states: '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.' malposition was found mentioned as a potential complication and adverse event.H10: d4 (expiry date: 08/2022), g3, h6 (method).H11: h6 (device, result and 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.H3 other text : device not returned.

Event Description

It was reported that during a stent placement procedure in the common and external iliac vein, the stent allegedly did not deploy.It was further reported that the stent deployed automatically and got deployed in the wrong vessel and ended up smashing it against the wall and onto another stent.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: 11433324
• MDR Text Key: 258840433
• Report Number: 9681442-2021-00123
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103711
• UDI-Public: (01)00801741103711
• 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: 03/10/2021

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: VENUM18080
• Device Catalogue Number: VENUM18080
• Device Lot Number: ANEV4061
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other