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

Catalog Number ZVM12060

Device Problems Break (1069); Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2020

Event Type  Death  

Manufacturer Narrative

A photo and four images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.(b)(4).

Event Description

It was reported that during treatment of a moderate to severe stenosis in the calcified common iliac via right groin access, ipsilateral approach, the stent allegedly partially deployed 4-5 cm and the tip of the delivery system allegedly broke and detached within the patient.Reportedly, the detached tip was firmly stuck in the stenosis and the healthcare provider (hcp) attempted to retrieve the detached tip for four hours but was unsuccessful.The patient was taken to the operating room to have the fragment removed and an aortobifemoral prosthetic placed in an open surgery.Reportedly, the patient expired two days post-procedure.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned sample and images provided a break of the distal outer catheter close to the tip was confirmed.The system was found in used condition, and the stent was found deployed; however, the broken and detached distal outer sheath including sheath marker was found over the deployed stent so that the stent was unexpanded in the mid section.The investigation indicated that a stent strut perforated the outer sheath during deployment which caused blockage and tip fracture/ detachment.The condition of the sample matched the reported event which led to a confirmed result for perforation.An indication for a manufacturing related issue could not be found.Based on the investigation of the provided information the complaint is confirmed for tip perforation leading to breakage.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential risk was found to be addressed.The ifu states: "potential adverse events associated with the use of the bard e-luminexx vascular stent include, but may not be limited to the usual complications reported for vascular procedures such as: detachment of a component of the system or emergent surgery to remove stent.¿ in addition, the ifu states: "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." regarding preparation the ifu states that the devices should be visually inspected to verify that the device has not been damaged due to shipping or improper storage.Damaged equipment should not be used.In addition, the system should be flushed with sterile saline at the two female luer ports until saline drips from the distal tip.The system should not be used if fluid is not observed exiting the catheter at the distal tip after each luer port is flushed.Based on the ifu supplied with this product the device is intended to be used in the iliac and femoral arteries.H10: h6(device code: 1528 - difficult to remove, 2205 - material perforation), g4, b7 h11: d10, h3, h6(methods, results, conclusion).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.

Event Description

It was reported that during treatment of a moderate to severe stenosis in the calcified common iliac via right groin access, ipsilateral approach, the stent allegedly partially deployed 4-5 cm and the tip of the delivery system allegedly broke and detached within the patient.Reportedly, the detached tip was firmly stuck in the stenosis and the healthcare provider (hcp) attempted to retrieve the detached tip for four hours but was unsuccessful.The patient was taken to the operating room to have the fragment removed and an aortobifemoral prosthetic placed in an open surgery.Reportedly, the patient expired two days post-procedure.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9887043
• MDR Text Key: 185175581
• Report Number: 9681442-2020-00070
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147227
• UDI-Public: (01)00801741147227
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2021
• Device Catalogue Number: ZVM12060
• Device Lot Number: ANCX2515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLOPIDOGREL 75MG.; CLOPIDOGREL 75MG.; CORODIL.; CORODIL.; SIMVASTATIN.; SIMVASTATIN.; CLOPIDOGREL 75MG; CORODIL; SIMVASTATIN
• Patient Outcome(s): Death