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

Catalog Number ZVM07060

Device Problems Improper or Incorrect Procedure or Method (2017); Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the e-luminexx vascular stent system products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent system products are identified.Manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported contamination as no objective evidence was provided for review.A definite root cause of the reported incident can not be identified based upon the available information.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the jifu states that 'visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is open or damaged.' regarding precautions, the jifu states 'non compliance with sterility precautions may lead to infectious complications'.(expiration date: 05/2024).

Event Description

It was reported that prior to a stent placement procedure, the device allegedly became filthy, upon removal from the packaging.It was further reported that another device was used to complete the procedure.There was no patient contact.

Manufacturer Narrative

The file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.The catalog number identified in section d4 has not been cleared in the us, but is similar to the e-luminexx vascular stent system products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent system products are identified in d2 and g4.D4 (expiration date: 05/2024).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.H3 other text : device not returned.

Event Description

It was reported that prior to a stent placement procedure, the device allegedly became filthy, upon removal from the packaging.It was further reported that another device was used to complete the procedure.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: 14370510
• MDR Text Key: 291487951
• Report Number: 9681442-2022-00151
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146909
• UDI-Public: (01)00801741146909
• 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,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM07060
• Device Lot Number: ANFS2079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• 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