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

Model Number	EX061503CS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review 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.
Event or Problem Description
It was reported that during a stent placement in the right superficial femoral artery via left femoral approach, the delivery system allegedly became detached from itself outside of the patient, after the healthcare provider attempted to remove the stent from the wire.Reportedly, the stent was successfully deployed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: this supplemental mdr is to notify this duplicate file was inadvertently opened.The reported event was captured under file (b)(4) and the investigation results will be submitted via a supplemental mdr under file (b)(4) upon completion of the investigation.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.
Event or Problem Description
It was reported that during a stent placement in the right superficial femoral artery via left femoral approach, the delivery system allegedly became detached from itself outside of the patient, after the healthcare provider attempted to remove the stent from the wire.Reportedly, the stent was successfully deployed.There was no reported patient injury.

• Brand Name: LIFESTENT STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9337681
• Report Number: 9681442-2019-00221
• Device Sequence Number: 1849532
• Product Code: FGE
• UDI-Device Identifier: 04049519001296
• UDI-Public: (01)04049519001296
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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 Expiration Date: 03/08/2021
• Device Model Number: EX061503CS
• Device Catalogue Number: EX061503CS
• Device Lot Number: ANDQ1417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1