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

Catalog Number 5F070403C

Device Problem Malposition of Device (2616)

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

Event Date 03/05/2024

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 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.H10: d4 (expiration 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.H3 other text : device not returned.

Event Description

It was reported that during a stent placement procedure in the superior femoral artery, accurate placement was not possible due to the stent allegedly got jumped.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure in the superior femoral artery, accurate placement was not possible due to the stent allegedly got jumped.The procedure was completed using another device.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 and the 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 issue.Investigation summary: the catheter sample is not available for evaluation and no images were provided for review.The target site was calcified, and measured 6mm in diameter; a 0.014" guidewire was in use, and the lesion was pre dilated; the stability sheath was held close to the introducer, and kept stationary, and slack was removed from the system held outside patient; the user started deployment using the large wheel.Therefore, 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 instruction for use closely describes holding and handling of the system throughout deployment.In particular the instruction for use state: 'hold the green stability sheath.Do not hold or touch the brown moving sheath.', 'confirm that the introducer sheath is secure and will not move during deployment.', 'remove slack from the stent system held outside the patient.Caution: any slack in the stent system (outside the patient) could result in deploying the stent beyond the target site.', and 'initiate stent deployment by rotating the large thumbwheel'.The instruction for use further state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.', and 'gain ipsilateral or contralateral femoral access utilizing 5f (1.67 mm) or larger introducer sheath.Insert a guidewire of appropriate length (table 3) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter '.A stent size selection table is part of the instruction for use describing the relationship between reference vessel diameter and unconstrained stent inner diameter; based on this table a 7mm stent is needed for a 6mm vessel.'stent misplacement' was found mentioned a potential complication/ adverse event.H10: d4 (expiration date: 07/2024), g3 h11: h6 (method) 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.H3 other text : 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: 19021566
• MDR Text Key: 339139530
• Report Number: 9681442-2024-00066
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120442
• UDI-Public: (01)00801741120442
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• 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: 03/05/2024
• 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