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

Catalog Number VENEM14040

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the lot history records of this lot were 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: a physical sample was not returned.X-ray images were provided but a stent fracture could not be identified which led an inconclusive evaluation result.In this case the lesion was pre dilated, the vessel was calcified and tortuous in nature.The placement in the upper chest/ arm section represents an off label use of the device.A manufacturing related root cause was considered.Based on the information available and because no sample was provided for evaluation, 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 ifu state: 'confirm that the introducer sheath is secure and will not move during deployment.Pull back the stent system until the distal and proximal stent radiopaque markers are in position so that they are distal and proximal to the target site.The second hand should be used to support the stent delivery system.Gently hold the stability sheath and maintain it straight and under tension throughout the procedure.Do not hold or touch the dark moving sheath during stent release.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: 'predilation of chronic lesions with a balloon dilatation catheter is recommended', and 'post stent expansion with a balloon dilatation catheter is recommended.' stent fracture was found addressed as a potential adverse event that may occur.The venovo venous stent system is indicated for the treatment of stenoses and occlusions in the iliac and femoral veins.The catalog number identified has not been cleared in the us but is similar to the venovo venous stent system products that are cleared in the us.The pro code and 510k number for the venovo venous stent system products is identified.

Event Description

It was reported that during a stent deployment procedure, the stent allegedly fractured.There was no reported patient injury.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10262647
• MDR Text Key: 199893872
• Report Number: 9681442-2020-00143
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741102226
• UDI-Public: (01)00801741102226(17)201109
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: VENEM14040
• Device Lot Number: ANCY1572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR