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

Catalog Number ZVL12080

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Misfire (2532); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

It was reported during the stent placement procedure, the device allegedly had a resistance upon advancing through the guidewire.It was further reported that the device was allegedly difficult to remove.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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 sample was returned for evaluation.One of the provided photos shows the stent delivery system on the table with a lying guidewire.The stent delivery system was returned for evaluation and the delivery system was detached from the handgrip at the level of the guiding tube connector/conversion tab but the t-luer was still secured in the slider.It is not known when and how the conversion tab got detached from the handgrip.The stent was found partially deployed though the system doesn't look activated using the handgrip.This is thought to be inadvertent premature activation of the stent during the reported difficulty to advance the system over the guidewire.A guidewire was stuck within the delivery system, and repeated attempts to pull the guidewire out of the delivery system failed which led to confirmed results for failure to advance and device-device incompatibility and partial deployment of the stent is considered a cascading event.It was reported that the device was flushed, and a 0.035" guidewire was used.Based on evaluation of the device sample returned, the reported issues could be confirmed.However, a definite root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use states that "flush the stent delivery system with sterile saline using a small volume (e.G., 5 ¿ 10 cc) syringe.Attach the saline filled syringe to the two female luer ports, the first of which is located at the proximal end of the device and the second of which is found within the t-luer adapter.Continue flushing until saline drips from the distal tip of the catheter after flushing each luer port".Regarding accessories, the instructions for use states "the bard s.A.F.E.R 6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath" also "via the femoral route, insert a 0.035¿(0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".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".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.Expiry date: 08/2024.

• 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: 15931262
• MDR Text Key: 308045937
• Report Number: 9681442-2022-00355
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146510
• UDI-Public: (01)00801741146510
• 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
• Report Date: 11/11/2022

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: ZVL12080
• Device Lot Number: ANFV2663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/07/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 68 KG