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

Model Number 5F051003CS

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent allegedly had a positioning problem.It was further reported that catheter allegedly buckled.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records 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.(expiry date: 10/2024).

Manufacturer Narrative

H10: manufacturing review: 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.The returned sample was found in locked condition with loaded stent; the outer stability sheath was found with compressive crinkles which may indicate insertion/ crossing difficulty.Images/ movie demonstrating crossing failure were not provided, however the provided information about the event and the compressive crinkles found lead to confirmed result for failure to advance leading to catheter deformation.Stent deployment was attempted via pedal access, the vessel was not tortuous but heavily calcified; the guidewire was running smoothly inside the system, and the lesion was not pre dilated; system compatible introducer and guidewire size were used for access.Therefore, the investigation is confirmed for failure to cross the lesion, and subsequent buckling.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' in regards to required materials and access the instructions for use states: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath.(.) insert a guidewire of appropriate length and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter across the lesion to be stented via the introducer sheath.' h10: d4 (expiry date: 10/2024), g3.H11: h6 (method, result).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.H3 other text : see h10.

Event Description

It was reported that during a stent placement procedure, the stent allegedly had a positioning problem.It was further reported that catheter allegedly buckled.There was no reported patient injury.

• 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: 15110827
• MDR Text Key: 302432411
• Report Number: 9681442-2022-00224
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120640
• UDI-Public: (01)00801741120640
• 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,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5F051003CS
• Device Catalogue Number: 5F051003CS
• Device Lot Number: ANFX1254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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