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

Catalog Number 5F070403C

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

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being 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.H10: d4 (expiry date: 07/2024).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 Description

It was reported that during a stent placement procedure in the superior femoral artery stenosis lesion via the contralateral approach, the catheter shaft was allegedly kinked.It was further reported that the device allegedly could not reach the lesion.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure in the superior femoral artery stenosis lesion via the contralateral approach, the catheter shaft was allegedly kinked.It was further reported that the device allegedly could not reach the lesion.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.H10: manufacturing review: the lot history records of this lot# were reviewed with special attention to the manufacturing and inspection of this product was found to have met the specification prior to shipment.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issues.Investigation summary: neither sample nor image provided which leads to inconclusive evaluation result.It was only known that a system compatible 5f introducer was in use.Based on the investigation of the provided information, the investigation is closed as inconclusive.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 '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'.The instructions for use further state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.', and 'examine the stent system to ensure it has not been damaged during shipment (.) if it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.' h10: d4 (expiry date: 07/2024), g3 h11: the initial mdr was inadvertently submitted with a g3 date of 12/07/2023.The correct g3 date is 12/06/2023.H11: b3 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.

• 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: 18408309
• MDR Text Key: 331498593
• Report Number: 9681442-2023-00410
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F070403C
• Device Lot Number: ANFU2860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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