MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

Catalog Number ZVL12100

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation; however, three photos are provided for review.The investigation of the reported event is currently underway.Expiry date (12/2022).Device not returned.

Event Description

It was reported that during a stent placement procedure through the left iliac vein following a puncture of the femoral vein, the device was allegedly found to be foreshortened.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure through the left iliac vein following a puncture of the femoral vein, the stent allegedly found to be foreshortened.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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: the delivery system was not provided for evaluation.The stent was implanted in the patient.Two x-ray images were provided for evaluation.Based on the x-rays placement in the left vena iliaca communis is confirmed.However, due to missing markings or length values verification of the reported stent foreshortening could not be performed.Potential factors which may have contributed to the reported issue have been considered.Therefore previous investigations of similar complaints have been reviewed.The image provided showed the placed stents but without measurement accessories and with poor resolution; therefore no definite assessment could be performed.Minimal changes in stent length may occur during deployment of the stent as stated in the instruction for use.Furthermore the stent might have become shortened due to the attempt of micro adjustments during deployment of the stent or due to unintentional movement of the handle during deployment.In this case the stent was placed in the iliac vein, which represents an off label use.As a result of the investigation performed the complaint is inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instruction for use sufficiently addressed the potential risks.Regarding stent placement the instruction for use states: "center the proximal stent markers (see figure a1, ¿b2¿) and both overlapping distal markers (see figure a1, stent markers ¿b1¿ and marker band on the outer catheter ¿c¿) across the stricture.The radiopaque markers on the stent indicate the ends of the compressed stent and the length of the expanded stent.By initially advancing the catheter beyond the stricture, micro-adjustments of the stent can be made by pulling the entire system back toward the stricture to improve placement accuracy.Once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should not be dragged or repositioned in the lumen." the reported use of the device in the iliac vein represents an off label use.Based on the instruction for use the bard® e-luminexx® vascular stent is indicated to be used in the iliac and femoral arteries.H10: d4 (expiry date: 12/2022).H11: h6 (method, result, conclusion).H11: section a through f ¿ the information provide by bd represents all 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: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10725878
• MDR Text Key: 212713594
• Report Number: 9681442-2020-20011
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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 Catalogue Number: ZVL12100
• Device Lot Number: ANDZ0936
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 50