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

Catalog Number ZVL12060

Device Problems Positioning Failure (1158); Malposition of Device (2616)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

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.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Based on the available information, the investigation is inconclusive for deployment failure/ malposition.A definite root cause of the reported incident can not 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 device warning, the instructions for use states that "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"."once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should not be dragged or repositioned in the lumen".Regarding accessories, the instructions for use states "the bard s.A.F.E.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.In regards to pta the instructions for use state: "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".(expiry date: 04/2024).

Event Description

It was reported that during a stent placement procedure via right femoral artery, the stent was allegedly failed to deploy.It was further reported that stent was dislodged from the delivery system away from stenosis into healthy vessel.There was no reported patient injury.

• 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: 13946631
• MDR Text Key: 289259820
• Report Number: 9681442-2022-00094
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146503
• UDI-Public: (01)00801741146503
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/08/2022

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: ZVL12060
• Device Lot Number: ANFR0090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 03/30/2022
• 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 Age: 61 YR
• Patient Sex: Male