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

Model Number VENUL16160

Device Problems Entrapment of Device (1212); Fracture (1260); Material Deformation (2976)

Patient Problem Extravasation (1842)

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 was 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 left iliac vein via right internal jugular vein approach, the stent allegedly fractured and mangled.The current status of patient is unknown.

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 returned sample was investigated but a deficiency leading to or indicating stent fracture or deformation could not be found.X-ray images were provided demonstrating the placed stent in the iliac vein entrapped with another stent and demonstrating strut deformation.A strut fracture could not be visualized, which led to a confirmed result for entrapment.Based on the information available the event is confirmed for entrapment with the previously placed stent; a stent fracture could not be identified.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: h6 (result, 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 left iliac vein via right internal jugular vein approach, the stent allegedly fractured and mangled.The current status of patient is unknown.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Type of Device: VENOVO VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10526679
• MDR Text Key: 206765371
• Report Number: 9681442-2020-00197
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR