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

Model Number VENUL16160

Device Problems Entrapment of Device (1212); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2020

Event Type  Injury  

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, image and video were provided for review.The investigation of the reported event is currently underway.Expiry date (05/2022).

Event Description

It was reported that during a stent placement procedure in right iliac vein for bilateral venous compression via right internal jugular vein approach, the stent allegedly broke and migrated to the heart.Current status of patient is unknown.

Manufacturer Narrative

H10:manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the returned sample was investigated but a deficiency leading to or indicating stent fracture could not be found.X-ray images, ultrasound (us) / intravascular ultrasound (ivus) images and movies were provided for evaluation.The us images/ movies demonstrated the left and right vessel before and after treatment, the stent strut structure was not visible.X-ray images were provided demonstrating the placed stent in the iliac vein entrapped with another stent and demonstrating the fractured radiopaque section in the chest which led to a confirmed result for stent fracture.In this case the stent could be deployed and post dilated without difficulty with a 16mm balloon with good result; pre dilation was not part of the detailed step by step description.Based on the information available the alleged stent fracture was confirmed.A definite root cause could not be determined.Labeling review: the relevant labeling supplied with this product was reviewed.Even though the cause for the problem occurred could not be determined, potential contributing factors were found to be addressed in the ifu.E.G.The ifu states: "recrossing a partially or fully deployed stent with adjunct devices must be performed with caution", and "if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit." regarding pta the ifu state: "predilation of chronic lesions with a balloon dilatation catheter is recommended", and "post stent expansion with a balloon dilatation catheter is recommended.If performed, select a balloon catheter that matches the size of the reference vessel, but that is not larger than the stent diameter itself." stent fracture was found addressed as a potential adverse event that may occur.H10: d4(expiry date: 05/2022), g4.H11: d2, h6(results, conclusion).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.

Event Description

It was reported that during a stent placement procedure in right iliac vein for bilateral venous compression via right internal jugular vein approach, the stent allegedly broke and migrated to the heart.The current status of patient is unknown.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Type of Device: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10526696
• MDR Text Key: 206765604
• Report Number: 9681442-2020-00198
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUL16160
• Device Catalogue Number: VENUL16160
• Device Lot Number: ANES3048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR