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

Catalog Number ZVM09080

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

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

Event Date 01/25/2023

Event Type  malfunction  

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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiration date: (expiry date: 09/2025).

Event Description

It was reported that during a stent placement procedure from the origin of the common iliac until the distal third of the same before the iliac bifurcation, the stent did not come out of its shaft for the most part and allegedly failed to deploy.It was further reported that at the end, the stent was positioned from the mid-distal third of the common iliac to the external iliac and, by pulling and disassembling the handpiece, it was possible to open the stent but not in the desired position.Reportedly, the stent allegedly had a caudal displacement of at least 3 cm.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure from the origin of the common iliac until the distal third of the same before the iliac bifurcation, the stent did not come out of its shaft for the most part and allegedly failed to deploy.It was further reported that at the end, the stent was positioned from the mid-distal third of the common iliac to the external iliac and, by pulling and disassembling the handpiece it was possible to open the stent but not in the desired position.Reportedly, the stent allegedly had a caudal displacement of at least three cm.The procedure was completed using another device.There was no reported patient injury.

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 stent delivery system was returned for evaluation and there was no stent in the delivery catheter, the slider was completely activated, and the delivery system was detached from the handgrip which matches the event description which mentioned that the handgrip was disassembled, and, in the process, the stent got deployed, which leads to inconclusive results for positioning failure.It was reported that the handgrip was disassembled, and, in the process, the stent got deployed to the undesired location.Based on available information and evaluation of the returned sample, the investigation is closed with inconclusive result for deployment failure.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.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".Regarding accessories, the instructions for use states "the bard s.A.F.E.R 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".Regarding pta the instructions for use states: "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The packaging pictograms indicate an introducer size of 6f and a 0.035" guide wire.H10: d4 (expiry date: 09/2025), g3.H11: h6 (result, 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.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: 16475449
• MDR Text Key: 310693998
• Report Number: 9681442-2023-00057
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147074
• UDI-Public: (01)00801741147074
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/28/2023

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: ZVM09080
• Device Lot Number: ANGW1267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/21/2023
• 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