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

Model Number VENUL18120

Device Problems Entrapment of Device (1212); Appropriate Term/Code Not Available (3191); Activation Failure (3270)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 01/2022).Device pending return.

Event Description

It was reported that during stent placement through iliac vein, the stent allegedly did not deploy correctly.It was further reported that the stent allegedly stuck in the iliac vein.Reportedly medical intervention was required to remove the stent.The patient current status was normal.

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 evaluation of the image and returned sample confirmed that the user experienced a deployment issue with the stent during deployment leading to interaction between stent and delivery system.The complete proximal stent end being undeployed leads to the conclusion that the issue was caused by a deployment issue.The provided image and the returned sample indicated that the stent fractured which was considered the consequence of the stent being stuck to the system upon removal.The provided image indicated a deployment issue rather than an expansion issue which led to a confirmed result for partial deployment.Based on the information available, 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.Regarding a potential deployment failure the instructions for use states: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.' 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 addition, 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: 01/2022), g3 h11: b3, h6(device, method, result, 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.

Event Description

It was reported that during stent placement procedure through iliac vein, the stent allegedly did not deploy correctly.It was further reported that the stent allegedly stuck in the iliac vein.Reportedly medical intervention was required to remove the stent.The patient current status was normal.

• 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: 10789779
• MDR Text Key: 214752092
• Report Number: 9681442-2020-20025
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103803
• UDI-Public: (01)00801741103803
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUL18120
• Device Catalogue Number: VENUL18120
• Device Lot Number: ANEN1102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention