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

Model Number	VENUL16160
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: VENOVO VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10526679
• Report Number: 9681442-2020-00197
• Device Sequence Number: 17037948
• Product Code: QAN
• UDI-Device Identifier: 00801741103681
• UDI-Public: (01)00801741103681
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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
• Operator of Device: 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 Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR