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

Catalog Number ZVM08080

Device Problems Fracture (1260); Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent products are identified in d2 and g4.H10: manufacturing review: 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 physical sample was not returned for evaluation.Provided videos show an overlappingly stented section and the resolution is poor.Single stent struts are poorly visible but at the proximal stent end only three stent markers are visible which leads to confirmed result for fracture of a stent marker.A migrated stent marker could not be identified on the videos.There was no indication of a manufacturing deficiency.Based on evaluation of the provided videos, the investigation is closed with confirmed result for stent fracture.A definite root cause of the reported incident can not be identified.The placement of this stent in a tips procedure represent an off-label use.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Holding and handling of the system during deployment was found addressed; in particular the instructions for use state: 'prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.During stent deployment, the entire length of the catheter system should be kept as straight as possible.Maintaining a straight catheter under slight tension during stent deployment is recommended to improve placement accuracy'.The instructions for use states, "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The instructions for use indicates 'stent fracture' as a malfunction and adverse event.The instructions for use states "the e-luminexx vascular stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery".H10: d4 (expiration date: 07/2022).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 : device not returned.

Event Description

It was reported that four years, two months and fourteen days post a stent placement, the patient allegedly had mark point development in the atrium.It was further reported that on careful observation the stent mark point was allegedly found to be broken with the blood flow in the atrium.Reportedly, upon review, it was found that the mark point has fallen.The was no reported patient injury.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent products are identified in d2 and g4.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 sample was not returned for evaluation.Provided videos show an overlappingly stented section and the resolution is poor.Single stent struts are poorly visible but at the proximal stent end only three stent markers are visible which leads to confirmed result for fracture of a stent marker.A migrated stent marker could not be identified on the videos.It was reported that there were no difficulties experienced during stent release, no follow-up treatment was done for the time being and no measures were taken to retrieve the alleged piece that was floating in the heart.Based on evaluation of the provided videos, the investigation is closed with confirmed result for stent fracture.A definite root cause of the reported incident cannot be identified.The placement of this stent in a tips procedure represent an off-label use.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Holding and handling of the system during deployment was found addressed; in particular the instructions for use state: 'prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.During stent deployment, the entire length of the catheter system should be kept as straight as possible.Maintaining a straight catheter under slight tension during stent deployment is recommended to improve placement accuracy'.The instructions for use states, "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The instructions for use indicates 'stent fracture' as a malfunction and adverse event.The instructions for use states "the e-luminexx vascular stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery".H10: d4 (expiration date: 07/2022), g3.H11: b5, h1, h6 (patient).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 : device not returned.

Event Description

It was reported that four years, two months, and fourteen days post a stent placement, the patient allegedly had mark point development in the atrium.It was further reported that on careful observation the stent mark point was allegedly found to be broken with the blood flow in the atrium.Reportedly, upon review, it was found that the mark point has fallen and the broken part was found to be floating in the heart parenchyma and no recall measures were taken.The current status of the patient is unknown.

• 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: 18683999
• MDR Text Key: 335823083
• Report Number: 9681442-2024-00018
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM08080
• Device Lot Number: ANDU2983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2024
• 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 Outcome(s): Required Intervention