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

Model Number 5F050603CS

Device Problems Difficult to Remove (1528); Misfire (2532); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in the left sfa, the stent partially deployed.It was further reported that the stent allegedly difficult to remove.There was no reported patient injury.

Manufacturer Narrative

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.The physical sample was not returned for investigation.However; a picture was sent by the customer for evaluation demonstrating the product outside patient after the event.The stent is partially deployed and deformed, and the catheter tip is dislocated in proximal direction so that the distal end of the inner catheter is visible which leads to confirmed result for tip detachment, partial deployment, stent deformation, and subsequent difficult removal.The alleged guidewire issue cannot be confirmed.No manufacturing issues were identified.Based on information available, the investigation is confirmed for partial deployment, and catheter tip detachment.Stent deformation, and difficult removal were considered cascading events.A definite root cause could not be identified 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: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' in regard to accessories the instructions for use state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.See ¿materials required¿ section insert a guidewire of appropriate length (table 2) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.' in regard to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' the instructions for use further state: '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.', and 'keep the device as straight as possible following removal from the packaging and while inserted in the patient.Failure to do so may impede the optimal deployment of the implant.Device not returned.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Type of Device: 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: 15309050
• MDR Text Key: 303573177
• Report Number: 9681442-2022-00250
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120626
• UDI-Public: (01)00801741120626
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5F050603CS
• Device Catalogue Number: 5F050603CS
• Device Lot Number: ANFZ2025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Race: White