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

Catalog Number 5F050803C

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent 5f vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent products are identified.Manufacturing review: 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 physical sample was returned for evaluation.The returned sample was found with correctly loaded stent, with activated deployment mechanism and with an open/ detached force transmitting joint.It was assumed that the release force was too high for the joint which confirms the alleged deployment failure.Based on the investigation of the provided information, the investigation is closed as confirmed for detachment of a force transmitting joint and subsequent failure to deploy.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: '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 regards to access and accessories the instructions for use state: 'gain ipsilateral or contralateral femoral access utilizing an (.) 5f (1.67 mm) or larger introducer sheath.(.) insert a guidewire of (.) 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.' holding and handling of the system throughout deployment was found described.(expiry date: 11/2024).

Event Description

It was reported that during a stent placement procedure, the stent allegedly failed to deploy.The procedure was completed using another device.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: 15822994
• MDR Text Key: 307802930
• Report Number: 9681442-2022-00332
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119903
• UDI-Public: (01)00801741119903
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 10/31/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 5F050803C
• Device Lot Number: ANFY3549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/18/2022
• 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