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

Model Number	VENUM16080
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Misfire (2532); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during a stent placement in the left common iliac vein via left common femoral approach, the stent allegedly failed to deploy more than 50%.Reportedly, a glove was caught in transition when the second catheter went into the third catheter.It was further reported that a hemostat was used to open the device and manually deploy the stent.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: as the lot number was provided, a lot history review was completed.Investigation summary: based on the investigation of the returned catheter sample and the detailed event description it could be confirmed that the deployment system was blocked when the user tried to release the stent.The system was found disassembled and a piece of the glove was found between two sheaths leading to system blockage, as reported.Although the stent was not part of the sample return, a partial deployment was considered as confirmed because the condition of the delivery system matched the reported event.An indication for a manufacturing related cause or contributing factor could not be found.As a result of information provided and the evaluation of the delivery system returned the complaint was confirmed.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 (ifu) state: 'do not hold or touch the dark moving sheath during stent release'; an image demonstrates the non touching area.In addition, the ifu state: '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.' 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 in the left common iliac vein via left common femoral approach, the stent allegedly failed to deploy more than 50%.Reportedly, a glove was caught in transition when the second catheter went into the third catheter.It was further reported that a hemostat was used to open the device and manually deploy the stent.There was no reported patient injury.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9344741
• Report Number: 9681442-2019-00226
• Device Sequence Number: 13999192
• Product Code: QAN
• UDI-Device Identifier: 00801741103575
• UDI-Public: (01)00801741103575
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2021
• Device Model Number: VENUM16080
• Device Catalogue Number: VENUM16080
• Device Lot Number: ANDV1267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 109