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

Catalog Number	VIUL14120
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 01/2026).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.Device pending return.
Event or Problem Description
It was reported that during a stent placement procedure, difficult to pull back when deploying the stent and the stent allegedly wouldn't fully deploy off the catheter.It was further reported that the top of the stent was open, the bottom of the stent was open, but in the middle seemed all crushed up.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure in the iliac vein, it was difficult to pull back when deploying the stent and the stent allegedly wouldn't fully deploy off the catheter.It was further reported that the top of the stent was open, the bottom of the stent was open, but in the middle seemed all crushed up.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 stent delivery system was returned for evaluation.The system was activated and the stent was completely deployed and not returned.No defect or the delivery system or indication for increased forces during deployment could not be identified.No images were provided to verify the reported issue of the placed stent.It was reported that the top and the bottom of the stent were open, but the middle seemed to be crushed.Based on information available, the investigation is closed with inconclusive result.A definite root cause of the reported incident cannot be identified.Labeling review: relevant labeling was reviewed.The instruction for use was found to address the reported issue of increased deployment forces: "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 to be used and preparation of the lesion the instruction 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" and "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." the reported use of the device for treatment of a iliac vein stenosis represents an off label use of the device.Regarding indication for use the instruction for use supplied with this product states: "the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms." h10: b5, d4 (expiry date: 01/2026), g3 h11: h6 (method, result, conclusion) h11:.
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 stent delivery system was returned for evaluation.The system was activated and the stent was completely deployed and not returned.No defect of the delivery system or indication for increased forces during deployment could not be identified.However, venogram images were provided for evaluation.Based on these an insufficient expansion of the stent placed in the iliac vein could be verified.It was reported that the top and the bottom of the stent were open, but the middle seemed to be crushed.Based on investigation completed, the reported incomplete expansion could be confirmed.However, a definite root cause of the reported incident cannot be identified.The reported use of the device for treatment of a iliac vein stenosis represents an off label use of the device.Labeling review: relevant labeling was reviewed.The instructions for use was found to address the reported issue of increased deployment forces: "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 to be used and preparation of the lesion 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" and "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The reported use of the device for treatment of a iliac vein stenosis represents an off label use of the device.Based on indication for use supplied with this product 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), h6 (method).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 in the iliac vein, it was difficult to pull back when deploying the stent and the stent allegedly wouldn't fully deploy off the catheter.It was further reported that the top of the stent was open, the bottom of the stent was open, but in the middle seemed all crushed up.There was no reported patient injury.

• Brand Name: LIFESTAR BILIARY STENT
• Common Device Name: 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: 18442693
• Report Number: 9681442-2023-00420
• Device Sequence Number: 15482343
• Product Code: FGE
• UDI-Device Identifier: 04049519005232
• UDI-Public: (01)04049519005232
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2024

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: VIUL14120
• Device Lot Number: ANHN0890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 05/06/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/09/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 65 KG
• Patient Race: White