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

Catalog Number ZVL14060

Device Problems Fracture (1260); Off-Label Use (1494); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2022

Event Type  Injury  

Event Description

It was reported that approximately three months post stent placement procedure in the right superior lobar bronchus, the stent allegedly broke.It was further reported that the fragments of the stent was left in the patient's body.The patient's current status is unknown.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo, an image and a video were provided for review.The investigation of the reported event is currently underway.(expiration date: 06/2023).

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo, an image and a video were provided for review.The investigation of the reported event is currently underway.(expiration date: 06/2023).

Event Description

It was reported that approximately three months post stent placement procedure in the right superior lobar bronchus, the stent allegedly broke.It was further reported that the fragments of the stent was left in the patient's body.The patient's current status is unknown.

Event Description

It was reported that approximately three months post stent placement procedure in the right superior lobar bronchus, the stent allegedly fractured.It was further reported that some fragments of the stent remain in the patient.The patient's current status is unknown.

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 sample was not returned to the manufacturer for evaluation.The provided photos and a video clip show two stents implanted in the lungs; based on the images, one end of the stent was broken off, completely detached and the broken piece of the stent which was reported to have been coughed out by the patient is shown on one image.Based on the information available and analysis of both photos and videos provided, the investigation is closed with confirmed results for "off-label" use.The placement site for this stent was the bronchus which represents 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 risks.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 placement site for this stent was in the lungs which represents off-label use.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.

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 sample was not returned to the manufacturer for evaluation.The provided photos and a video clip show two stents implanted in the lungs; based on the images, one end of the stent was broken off, completely detached and the broken piece of the stent which was reported to have been coughed out by the patient is shown on one image.Based on the information available and analysis of both photos and videos provided, the investigation is closed with confirmed results for "off-label" use.The placement site for this stent was the bronchus which represents 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 risks.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 placement site for this stent was in the lungs which represents off-label use.H10: d4 (expiry date: 06/2023), g3, h6 (device) 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.

Event Description

It was reported that approximately three months post stent placement procedure in the right superior lobar bronchus, the stent allegedly broke.It was further reported that the fragments of the stent was left in the patient's body.The patient's current status is unknown.

Manufacturer Narrative

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 sample was not returned to the manufacturer for evaluation.However, provided photos and a video clip show two stents implanted in the lungs; based on the images, one end of the stent was broken off, completely detached and the broken piece of the stent which was reported to have been coughed out by the patient is shown on one image.Based on the information available and analysis of both photos and videos provided, the investigation is closed with confirmed results for "off-label" use.The placement site for this stent was the bronchus which represents 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 risks.With regards to indications for use, the ifu states that the stent is to be used on femoral and iliac arteries.Based on reported information, the placement site for this stent was in the lungs which represents off-label use.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.Device not returned.

Event Description

It was reported that approximately three months post stent placement procedure in the right superior lobar bronchus, the stent allegedly fractured.It was further reported that some fragments of the stent remain in the patient.The patient's current status 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: 13582880
• MDR Text Key: 286146120
• Report Number: 9681442-2022-00045
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146589
• UDI-Public: (01)00801741146589
• 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,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVL14060
• Device Lot Number: ANET3644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/09/2022; 03/17/2022; 06/13/2022
• Supplement Dates FDA Received: 03/11/2022; 03/21/2022; 06/15/2022
• 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; Other
• Patient Age: 54 YR
• Patient Sex: Male