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

Catalog Number ZBM14040

Device Problems Premature Activation (1484); Misfire (2532)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in the iliac lesion via left common femoral access, the stent was allegedly partially deployed despite still having the safety on.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: 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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2025).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.

Manufacturer Narrative

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 the stent was found partially deployed.The condition of the sample confirms that the deployment mechanism was not activated.A photo of the device box was provided but did not contribute to the investigation.The investigation leads to confirmed results for premature deployment.It was reported that the vessel was neither calcified nor tortuous, the lesion was pre-dilated, a 6f introducer was used for access but the specifications of the used guidewire were not provided.Another device was used to complete the procedure.Based on available information and the condition of the returned sample, the investigation is closed with confirmed results for premature deployment.A definite root cause of the reported issue cannot be identified.The reported use of the device in the iliac vessel represents an off-label use.Labeling review: relevant labeling was reviewed and the instructions for use was found to sufficiently address the potential risks.Regarding general 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 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.Via the transhepatic route, insert a 0.035¿(0.89 mm) guidewire under fluoroscopic guidance through the biliary stricture and into the duodenum".Regarding general directions, 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" guidewire.The bard e-luminexx biliary stent is indicated for the treatment of biliary strictures resulting from malignant neoplasms.The reported use of the device in the iliac vessel represents an off-label use.(expiration date: 10/2025).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 the iliac lesion via left common femoral access, the stent was allegedly partially deployed despite still having the safety on.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: E-LUMINEXX BILIARY STENT
• Type of Device: BILIARY 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: 17629461
• MDR Text Key: 322034727
• Report Number: 9681442-2023-00306
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 04049519010434
• UDI-Public: (01)04049519010434
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

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: ZBM14040
• Device Lot Number: ANGX3791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/10/2023
• 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
• Patient Sex: Male
• Patient Weight: 95 KG