MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM

Model Number 5F060603CS

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not 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 Description

It was reported that during a stent placement procedure in the right femoral artery, an angiogram allegedly identified two free flowing foreign bodies in the right common iliac artery.The patient was then moved to the operating room for open operative retrieval of the foreign bodies where one was successfully retrieved and the second piece was unable to be retrieved.It was further reported that the two foreign bodies were identified as fragments of the delivery system that allegedly broke and detached in the patient.The patient was reportedly stable post removal procedure and discharged from the hospital.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9777341
• MDR Text Key: 182333824
• Report Number: 9681442-2020-00057
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120169
• UDI-Public: (01)00801741120169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2020

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
• Device Operator: Health Professional
• Device Model Number: 5F060603CS
• Device Catalogue Number: 5F060603CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention