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

Catalog Number ZVL06080

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

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 stent delivery system was returned for evaluation and the stent was found partially deployed.The condition of the sample confirms that the deployment mechanism was not in use.The investigation leads to confirmed results for premature activation.Also photos of the device were provided previously, which show the safety clip still well placed on the handle, the slider at the extreme distal end and the stent partially deployed.Based on the provided photos and the returned sample, the investigation is closed with confirmed results for premature deployment.A definite root cause of the reported incident cannot be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to general warnings, 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".H10: d4 (expiry date: 04/2024).H11: section a through f - the information provided by bd represents all of 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: see h10.

Event Description

It was reported that prior to stent placement procedure, device allegedly damaged upon opening the package.The procedure was completed using another device.There was no patient contact.

• 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: 17743011
• MDR Text Key: 323368178
• Report Number: 9681442-2023-00323
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146114
• UDI-Public: (01)00801741146114
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVL06080
• Device Lot Number: ANFR2685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• 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