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

Catalog Number ZVM10040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Thrombosis/Thrombus (4440)

Event Date 01/07/2022

Event Type  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 510 k number for the e-luminexx vascular stent products are identified.Manufacturing review: the lot history record of this lot was 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 for evaluation and photos were not provided.Based on the information available, investigation is inconclusive for thrombosis/necrosis.A definite root cause of the reported incident cannot be identified based upon the available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risk.Based on the instructions for use, complications and adverse events associated with the use of the e-luminexx stent may include the usual complications associated with endovascular stent and covered stent placement which include "thrombosis at puncture site or remote site", "bleeding from anticoagulant or antiplatelet medications" and "embolization, distal (air, tissue or thrombotic emboli)".The instructions for use also states "the 6fr delivery system requires a minimum 6f introducer sheath.The delivery system has a soft and flexible catheter tip formed from the outer catheter.The catheter tip is tapered to accommodate a 0.035¿(0.89 mm) guidewire".The instructions for use further state: "after stent deployment, carefully withdraw the delivery system from the patient over the guidewire.After removing the delivery system, visually confirm that the entire stent delivery system has been removed.".

Event Description

It was reported that eighteen days post stent placement procedure through the iliac artery, the patient allegedly developed thrombus and the patient's fingertip became necrotic.The current status of the patient is unknown.

• 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: 13451369
• MDR Text Key: 285049689
• Report Number: 9681442-2022-00010
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147128
• UDI-Public: (01)00801741147128
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM10040
• Device Lot Number: ANDZ0961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 45 KG