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

Model Number	VIUS08060
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2025).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 : device not returned.
Event or Problem Description
It was reported that during a stent placement procedure in left arm venous anastamosis, the stent allegedly did not fully opened even after ballooning.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure in left arm venous anastamosis, the stent allegedly did not fully opened even after ballooning.There was no reported patient injury.
Additional 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 not returned for evaluation.However, x-ray images were provided for review.Based on x-ray photos provided a decreased diameter of the placed stent could be determined.However, no irregularity of stent struts could be determined, and the investigation is closed with inconclusive result.The device was used in a venous anastomosis in a dialysis fistula, which represents an off label use of the device.The stent post dilated using an 8mm balloon catheter.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the alleged issue could not be determined.The reported use of the device represents an off label use of the device.Labeling review: the relevant labeling supplied with this product was reviewed and the potential risk associated with the reported issue was addressed.Regarding stent selection the instruction for use states: "appropriate diameter sizing of the stent to the target lesion is required to reduce the possibility of stent migration.(.) the stent should be approximately 1 mm larger in diameter than the target lumen." regarding predilation the instruction for use states: "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." regarding post dilation the instruction for use states: "post-dilatation of the stent with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." the reported use of the device in a venous anastomosis in a dialysis fistula represents an off label use of the device.Based on the instruction for use supplied with this product the bard® lifestar¿ vascular stent system is indicated for the treatment of illiac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries.H10: d4 (expiry date: (b)(6) 2025), g3 h11: h6 (method, 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 : device not returned.

• Brand Name: LIFESTAR BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND 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: 17037143
• Report Number: 9681442-2023-00209
• Device Sequence Number: 6393637
• Product Code: FGE
• UDI-Device Identifier: 04049519005416
• UDI-Public: (01)04049519005416
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: VIUS08060
• Device Catalogue Number: VIUS08060
• Device Lot Number: ANGU1893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 109 KG