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

Catalog Number ZVM07040

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 12/27/2021

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the device allegedly could not be delivered to the target lesion and the tip of the delivery system was found to be peeled off.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified 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 510k number for the e-luminexx vascular stent products is identified.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 stent delivery system was not returned and photos were not available for evaluation.Based on the information available, the reported inability of the delivery system to be delivered to the target lesion and material deformation can not be confirmed.The investigation is closed with inconclusive result for "material deformation/positioning problem".A definite root cause of the reported incident cannot be identified.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 general warnings, the instructions for use states that "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit".Regarding potential damages, the instructions for use states: "visually inspect the bard e-luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".Regarding preparation the instructions for use states that "prior to inserting the delivery catheter over the guidewire, the system must be flushed with sterile saline at the two female luer ports until saline drips from the distal tip of the catheter.Flushing lubricates the surface between the inner and outer catheters".Regarding procedural access, the ifu states "gain access to the treatment site utilizing appropriate accessory equipment compatible with the 6fr bard® e¿luminexx® vascular stent system.(1) via the femoral route, insert a 0.035¿ (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion.(2) the delivery system requires a minimum 6fr introducer sheath".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.(expiry date: 06/2022).

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13312110
• MDR Text Key: 285672239
• Report Number: 9681442-2021-00664
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146886
• UDI-Public: (01)00801741146886
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/29/2021

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: ZVM07040
• Device Lot Number: ANDT0780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/20/2022
• 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