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

Model Number	VENUL14140
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was not returned for evaluation.The investigation is currently underway.(expiry date: 01/2021).
Event or Problem Description
It was reported that during treatment of the left common iliac and left external iliac vein via great saphenous vein, after the stent had begun to deploy, the healthcare provider (hcp) realized that the stent should be placed lower and attempted to move the stent to the desired location; however, the movement caused the stent to allegedly fracture into two segments.Therefore, the stent was completely deployed in the external iliac and common femoral vein.It was further reported that a pta balloon and an additional stent of a different size were used to cover the entirety of the lesion, completing the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during treatment of the left common iliac and left external iliac vein via great saphenous vein, after the stent had begun to deploy, the healthcare provider (hcp) realized that the stent should be placed lower and attempted to move the stent to the desired location; however, the movement caused the stent to allegedly fracture into two segments.Therefore, the stent was completely deployed in the external iliac and common femoral vein.It was further reported that a pta balloon and an additional stent of a different size were used to cover the entirety of the lesion, completing the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was provided, and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of images provided a stent fracture could not be confirmed.The images documented two stents placed into one another.Minor irregularity was visible at the overlapping zone which may indicate elongation or fracture, however, due to poor resolution a detailed strut structure was not visible, and an adequate length measurement was not possible.A movie documenting stent fracture during deployment was not provided; it was not known whether the stent potentially fractured or elongated as a consequence of the reported stent system dragging during stent deployment.Based on the information available, the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: based on the lot number reported, the instructions for use (ifu) were supplied with the product.They are currently valid, and therefore relevant for review.In reviewing the relevant labeling for this product the potential issue was found addressed.The ifu state: 'initiate stent deployment by rotating the large thumbwheel in the direction of the arrows while holding the handle in a fixed position while using fluoroscopy, maintain position of the distal and proximal stent radiopaque markers relative to the targeted site.Watch for the distal stent radiopaque markers to begin separating; separation of the distal stent radiopaque markers signals that the stent is deploying.Continue turning the large thumbwheel until the distal end of the stent obtains complete wall apposition'.The ifu further state 'the stent is not designed for repositioning or recapturing.', and stent fracture was found addressed as a potential adverse event that may occur.H10: (expiry date: 01/2021).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.

• 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: 9317452
• Report Number: 9681442-2019-00215
• Device Sequence Number: 1961957
• Product Code: QAN
• UDI-Device Identifier: 00801741103537
• UDI-Public: (01)00801741103537
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare 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 Model Number: VENUL14140
• Device Catalogue Number: VENUL14140
• Device Lot Number: ANDN1805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 11/13/2019
• 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: 52 YR
• Patient Weight: 79