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

Catalog Number ZVL07120

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Activation Failure (3270)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

It was reported that during a stent graft deployment procedure via right common femoral artery, the mid part of the stent was allegedly did not open.It was further reported that the stent delivery system stuck heavily over the wire and whole system come out with the stent.Then removed from the system forcefully.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 03/2024).

Manufacturer Narrative

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 sample was returned to the manufacturer for evaluation.Based on evaluation of the returned sample, the stent was fully deployed, the entire lumen of the delivery system could be flushed and a 0.035i guide wire could go through the delivery system successfully which leads to inconclusive results.Therefore, the investigation is inconclusive for the reported issues.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 device warnings, the instructions for use state "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".Regarding preparation of the device the instructions for use states that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).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.With regards to general warnings, 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".H10: d4 (expiry date: 03/2024), g3, h6 (device) 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.

Event Description

It was reported that during a stent graft deployment procedure via right common femoral artery, the mid part of the stent was allegedly did not open.It was further reported that the stent delivery system stuck heavily over the wire and whole system come out with the stent.Then removed from the system forcefully.The procedure was completed using another device.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14546030
• MDR Text Key: 293502151
• Report Number: 9681442-2022-00166
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146213
• UDI-Public: (01)00801741146213
• 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,Followup
• Report Date: 06/20/2022

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: ZVL07120
• Device Lot Number: ANFQ3315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 06/22/2022
• 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 Age: 72 YR
• Patient Sex: Male