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

Catalog Number ZVL14100

Device Problems Malposition of Device (2616); Material Deformation (2976)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure for percutaneous transhepatic biliary drainage stenting, while the physician pressed the trigger and waited for the wall opposition, the proximal end of the stent allegedly jumped and shrunk within the bile duct.It was further reported that the stent was allegedly foreshortened and ended up being 6 cm than the actual length of 10 cm.The procedure was completed by placing an additional stent.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2025).

Manufacturer Narrative

H10: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was returned for evaluation without the stent as it was already deployed in the patient.Images or videos demonstrating stent jumping or foreshortening were not provided.The alleged issue could not be reproduced which leads to inconclusive evaluation result.It was reported that the stent allegedly foreshortened, the lesion was calcified, and pre-dilation was performed, and no resistance was encountered either during advancement of the device or deployment, the product was used in the biliary system which is off label.It was also reported that the stent foreshortened but fluoroscopic images with a digital scale were not provided for evaluation.Based on analysis of the returned sample, the investigation was closed with inconclusive result for malposition of device and stent foreshortening.A definite root cause for the reported event could not be determined.The placement in the biliary system represents off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.The instructions for use contains a table describing the relationship between unconstrained stent diameter and reference lumen vessel diameter.With regards to stent placement precautions, the instructions for use states "the stent experiences minimal length changes during deployment.To maximize stent placement accuracy, slowly and deliberately deploy the distal portion of the stent until you have visual confirmation of wall apposition before steadily deploying the remaining length of the stent".Regarding potential complications, the instructions for use states "stent malposition (failure to deliver the stent to the intended site)".With regards to indications for use, the instructions for use states that the stent is to be used on femoral and iliac arteries.Based on reported information, the intended placement site for this stent was the biliary system which represents off-label use.H10: d4 (expiration date: 06/2025), g3 h11: h6 (method, result, conclusion) h11: section a through f ¿ the information provided 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.H3 other text : see h10.

Event Description

It was reported that during a stent placement procedure for percutaneous transhepatic biliary drainage stenting, while the physician pressed the trigger and waited for the wall opposition, the proximal end of the stent allegedly jumped and shrunk within the bile duct.It was further reported that the stent was allegedly foreshortened and ended up being 6 cm than the actual length of 10 cm.The procedure was completed by placing an additional stent.There was no reported patient injury.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16494030
• MDR Text Key: 311109529
• Report Number: 9681442-2023-00069
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146602
• UDI-Public: (01)00801741146602
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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: ZVL14100
• Device Lot Number: ANGT1893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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