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

Catalog Number ZVM12100

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the catheter allegedly got stuck with the wire after stent deployment.It was further reported that the catheter and guidewire were removed together to complete the procedure.There was no reported patient injury.

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 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 issues.Investigation summary: the sample was returned for evaluation.The retuned catheter sample was found in deployed configuration, and with inserted guidewire.The outer catheter was found with superficial compressive crinkles which may be a consequence of holding the catheter while trying to heavily pull on a stuck guidewire, however, during device testing, the guidewire could be successfully removed from the system at regular force level.The reported difficult removal related to a stuck guidewire could not be re produced which leads to inconclusive evaluation result.But compressive crinkles on the outer catheter surface lead to confirmed result for catheter deformation.Based on the investigation of the provided information, the investigation is closed as confirmed for compressive deformation found on the outer catheter.A definite root cause for the reported event could not be determined.Labeling/packaging review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: '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 instructions for use further state: 'the e-luminexxvascular stent is only compatible with a 0.035 inch (0.89 mm) guidewire.', and 'during system flushing, do not use the system if fluid is not observed exiting the catheter at the distal tip.' regarding pta the instructions for use state: 'pre-dilatation of the stricture is recommended.' h10: d4 (expiration date: 07/2024).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.

• 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: 18167569
• MDR Text Key: 328484831
• Report Number: 9681442-2023-00375
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147241
• UDI-Public: (01)00801741147241
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: UNKNOWN
• 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: 11/06/2023

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: ZVM12100
• Device Lot Number: ANFU3070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/20/2023
• 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