MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR BILIARY STENT; VASCULAR STENT

Catalog Number	VIUS10120
Medical Device Problem Codes	Misfire (2532); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: 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 not returned for evaluation but provided images show the stent which is fully deployed in the basilic vein, with an irregular shape due to elongation and blood flow has been re-established which leads to confirmed results for stent elongation.It was reported that a 7f introducer / 0.035" guidewire were used for access, the tracking vessel was neither tortuous nor calcified, the lesion was pre-dilated.The intended placement of the device in the proximal basilic vein represents an off-label use.Based on the available information and evaluation of the provided images, the investigation is closed with confirmed results for stent elongation.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.Regarding 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 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".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to the procedure, 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 instructions for use states, "the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms".H10: d4 (expiration date: 01/2026) 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 or Problem Description
It was reported that during a stent placement procedure via proximal basilic vein, the stent allegedly did not deploy completely.It was further reported that the back end of the stent allegedly did not come out.Reportedly, the healthcare professional tried to push forward the stent out, but it ended up elongating the stent.There was no reported patient injury.

• Brand Name: LIFESTAR BILIARY STENT
• Common Device Name: 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: 19403532
• Report Number: 9681442-2024-00125
• Device Sequence Number: 20527379
• Product Code: FGE
• UDI-Device Identifier: 04049519005584
• UDI-Public: (01)04049519005584
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: VIUS10120
• Device Lot Number: ANHN1736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Black Or African American