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

Model Number	VIUS14080
Medical Device Problem Codes	Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/16/2021
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 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: 04/2020).
Event or Problem Description
It was reported that post device implant, the stent allegedly detached into a fragment resulting in distal bowel obstruction.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: this supplemental mdr is being submitted to report that mfr rpt# was a duplicate recor (b)(4) and was reported to the fda under mfr rpt# 9681442-2021-00435.H10: d4 (expiry date: 04/2020), g3.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 post device implant, the stent allegedly detached into a fragment resulting in distal bowel obstruction.The current status of the patient is unknown.

• Brand Name: LIFESTAR VASCULAR STENT
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12305759
• Report Number: 9681442-2021-00436
• Device Sequence Number: 3682842
• Product Code: FGE
• UDI-Device Identifier: 04049519005706
• UDI-Public: (01)04049519005706
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2020
• Device Model Number: VIUS14080
• Device Catalogue Number: VIUS14080
• Device Lot Number: ANBR1027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 01/31/2022
• 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: Required Intervention
• Patient Sex: Unknown