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

Model Number	5F051003CS
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
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 device has been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.Expiration date: 05/2025.
Event or Problem Description
It was reported that during a stent placement procedure through femoral artery, the stent allegedly detached into pieces.It was further reported that there was a light tension when initially retracting the stent from deployment location.Reportedly, the detached segments were removed using snare.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: 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 returned for evaluation and images were provided for evaluation.The returned delivery system was found in used condition without stent, which reportedly had been deployed inside patient.The inner catheter cardan tube was found broken at the distal end, and a segment of the cardan tube was missing; reportedly all pieces were removed using a snare.Images were provided demonstrating the broken and detached segments inside the vessel.The investigation leads to confirmed result for inner catheter cardan tube break and detachment.The vessel was not tortuous/ calcified, 5f introducer with an 0.035¿ guidewire was used for access.Based on the information available the investigation is closed with confirmed result for inner catheter cardan tube break.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' regarding pre dilation the instructions for use states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use states: '5f (1.67 mm) or larger introducer sheath (¿); 0.014-inch (0.36 mm) - 0.035-inch (0.89 mm) diameter guidewire'.Regarding insertion and removal difficulty of the delivery system the instructions for use states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' holding and handling of the system throughout deployment was found sufficiently described.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 through femoral artery, the stent allegedly detached into pieces.It was further reported that there was a light tension when initially retracting the stent from deployment location.Reportedly, the detached segments were removed using snare.There was no reported patient injury.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Common Device Name: VASCULAR 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: 16264018
• Report Number: 9681442-2023-00009
• Device Sequence Number: 19934113
• Product Code: NIP
• UDI-Device Identifier: 00801741120640
• UDI-Public: (01)00801741120640
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• 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): 03/03/2023

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: 5F051003CS
• Device Catalogue Number: 5F051003CS
• Device Lot Number: ANGS2126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/21/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 100 KG