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

Catalog Number ZVL06100

Device Problems Misfire (2532); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

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.The catalog number 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.(expiry date: 10/2022).

Event Description

It was reported that prior to a stent placement, the device allegedly had incompatibility issues between guidewire and sheath.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 stent delivery system was returned for evaluation.The stent was shifted to the distal end but did no protrude out of the tip of the delivery catheter.In addition, the outer sheath of the delivery system was found kinked distal to the blue swivel nut.While the kink is assessed to be likely caused during reshipment of the complaint sample, the partial stent deployment was likely a consequence of the reported problems to load the guidewire.The entire lumen of the delivery system was successfully flushed till liquid was found dripping at the distal end without any problems.A 0.035i pre-wetted guide wire was advanced through the delivery system successfully.However, the customer reported that during flushing, saline passed through the lumen with poor potency.Based on the evaluation of the returned device, the entire lumen of the stent delivery system could be flushed from both ports until liquid dripped from the distal end of the catheter without any problems.A 0.035i pre-wetted guide wire freely moved through the entire sheath.The stent was found shifted to the distal end but did not protrude out of the tip of the delivery catheter and the inner catheter was found protruding by 1 mm, these were considered to be related to the reported resistance when passing the guide wire through the sheath.Based on the returned sample evaluation, reported compatibility issues could not be reproduced.However, the stent was found partially deployed, which is considered to be consequence of the reported problems to load the device to the guidewire.A definite root cause of the reported incident cannot be identified.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks and contributing factors.With regards to warnings, the instructions for use 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 instructions for use states that "flush the stent delivery system with sterile saline using a small volume (e.G., 5 ¿ 10 cc) syringe.(.) continue flushing until saline drips from the distal tip of the catheter (d) after flushing each luer port." 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'.The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.H10: d4 (expiry date: 10/2022), g3 h11: h6 (result, conclusion) h11: section a through f ¿ the information provide 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.

Event Description

It was reported that prior to a stent placement, the device allegedly had incompatibility issues between guidewire and sheath.There was no patient contact.

• 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: 12073465
• MDR Text Key: 258635650
• Report Number: 9681442-2021-00376
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/11/2021

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: ZVL06100
• Device Lot Number: ANDX5584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/16/2021
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG