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

Model Number	VIUS12040
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 09/2023).
Event or Problem Description
It was reported that during stent deployment procedure, the stent was allegedly broken.There was no reported patient injury.
Event or Problem Description
It was reported that the stent allegedly broke respectively fractured during stent deployment procedure in cephalic vein.There was no reported intervention required and the device was removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 sample was not returned for evaluation and image was not provided for review.The lesion was pre dilated, and no difficulty was experienced during deployment, and the system was removed without incident.The product was used in the cephalic vein which is off label.The alleged issue cannot be re produced which leads to inconclusive evaluation result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.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 damage of the device prior to use the instructions for use states: 'visually inspect the bard lifestar biliary stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.' the instructions for use further states: 'complete stent deployment can be fluoroscopically visualized when the radiopaque markers at the proximal and distal ends of the stent are fully expanded.' regarding preparation the instructions for use states: 'the bard lifestar biliary stent is a self-expanding nitinol stent that must not be expanded beyond its labeled diameter by dilatation with a pta balloon.' the reported indication for this device represents an off label use.The instructions 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.' and 'the safety and effectiveness of this device for use in the vascular system have not been established.' h10: b5, d4 (expiry date: 09/2023), g3 h11: e1, h6 (device, method) 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: 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11965114
• Report Number: 9681442-2021-00366
• Device Sequence Number: 4268734
• Product Code: FGE
• UDI-Device Identifier: 04049519005614
• UDI-Public: (01)04049519005614
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/29/2021

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: VIUS12040
• Device Catalogue Number: VIUS12040
• Device Lot Number: ANEW0341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown