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

Catalog Number ZVM08030

Device Problems Break (1069); Fracture (1260); Misfire (2532)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent are identified in d2 and g4.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.D4 (expiry date: 11/2025).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.

Event Description

It was reported that during a stent placement procedure in left iliac artery via left femoral access, the distal part of the stent has deployed however, proximal part of the device was allegedly not deployed.It was further reported that the sheath was allegedly suspected to be ruptured.Reportedly the stent was removed through surgery and patient undergone bypass surgery.The patient is reported to be stable now.

Event Description

It was reported that during a stent placement procedure in the left iliac artery via the left femoral access, the distal part of the stent has deployed however, the proximal part of the device was allegedly not deployed.It was further reported that the sheath was allegedly suspected to be ruptured during the pull back.Furthermore, the stent was tried to be opened with force using a balloon mounted on the guidewire and was brought into the critical zone but was impossible to open.Reportedly the stent was lowered to the puncture point and the patient underwent bypass surgery, and the stent was surgically extracted.The patient is reported to be stable now.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent are identified in d2 and g4.H10: 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 delivery system was returned for evaluation.Based on the condition of the sample returned breakage of the distal end of the outer sheath, as well as detachment of the inner catheter is confirmed.As a segment of the stent was returned as well, the alleged stent fracture could be also confirmed.A segment of the balloon catheter used during the attempt to open respectively remove the stent was returned as well.A cd with dicom images was provided for evaluation.The cd contains x-ray images and angiographic images of the iliac bifurcation, the aorta and the arteries of both lower extremities.The condition of a partially deployed stent in the left iliac artery is documented, about half of the stent was found properly expanded while the other half was still loaded in the sheath.Based on information provided it is reasonably suggested that the stent catheter of the delivery system was torn off during retraction of the delivery system.Other images are documenting the attempts to post dilate the stent segment still covered by the sheath, respectively the effort of the physician to remove the stent using a snare.The stent was intended to be placed in the iliac artery and no difficult tracking anatomy was reported; as reported the lesion was predilated.A 0.018 inch guide wire was used, even though the instructions for use states that the device is only compatible with a 0.035 inch guidewire.Therefore, based on evaluation of the sample returned and x-ray images provided, the reported event is confirmed; the stent was found to be partially deployed inside the patient, and the delivery systems catheter and the stent implant were found to be broken respectively fractured.However, a definite root cause for the event could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.Potential complications and adverse events that may occur during use of this product were found addressed in the instruction for use ; e.G.,., stent fracture, stent kinking / collapse, stent migration, stent misplacement, stent thrombosis / occlusion or surgical intervention.Regarding appropriate accessory required to gain access to the treatment site the instruction for use states: "the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the femoral route, insert a 0.035 inch (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion.Pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." correct stent deployment as well different stent deployment options using the the performaxx grip as well as using the conventional method were found properly described.H10: b5, d4 (expiry date: 11/2025), g3 h11: h6 (method, result, conclusion) 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.H3 other text : see h10.

• 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: 18909889
• MDR Text Key: 337730981
• Report Number: 9681442-2024-00044
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146954
• UDI-Public: (01)00801741146954
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZVM08030
• Device Lot Number: ANGY1266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male