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

Model Number	5F051703CS
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
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.The investigation of the reported event is currently underway.(expiry date: 10/2024).
Event or Problem Description
It was reported that during a stent placement procedure, the guidewire was allegedly stuck in the delivery system and then guidewire was allegedly not able to be removed, stent couldn't deploy.It was further reported that the delivery system had the thumb wheel was allegedly broken.Reportedly, the health care provided had to remove the guidewire and the delivery system as a single unit.The procedure was completed using another device.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 returned to the manufacturer for evaluation.The returned catheter sample was found with locked safety slider, with undeployed stent and with an inserted guidewire.During evaluation testing, the guidewire could be easily removed from the system, and the stent could be successfully deployed on the table after unlocking the safety slider.A break could not be found.The reported issues could not be reproduced which leads to inconclusive evaluation result.A process related issue could not be found.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 state: '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.' in regards to the safety slider the instructions for use state: 'prior to deployment, the safety lock slider (f) must be unlocked.', and 'unlock the safety lock slider by pulling it back towards the wheels from the locked position into the unlocked position.Ensure that the red safety lock slider is completely pulled back'.In regards to guidewire removal difficulty the instructions for use state: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' h10: d4 (expiry date: 10/2024), g3 h11: section a through f ¿ the information provide 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, the guidewire was allegedly stuck in the delivery system and then guidewire was allegedly not able to be removed, stent couldn't deploy.It was further reported that the delivery system had the thumb wheel was allegedly broken.Reportedly, the health care provided had to remove the guidewire and the delivery system as a single unit.The procedure was completed using another device.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: 14098056
• Report Number: 9681442-2022-00111
• Device Sequence Number: 14668907
• Product Code: NIP
• UDI-Device Identifier: 00801741120664
• UDI-Public: (01)00801741120664
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/12/2022

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: 5F051703CS
• Device Catalogue Number: 5F051503CS
• Device Lot Number: ANFX3022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/18/2022
• 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 Sex: Unknown