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

Model Number 5F060403CS

Device Problems Break (1069); Positioning Failure (1158)

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

Event Date 04/16/2021

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the stent allegedly would not deploy.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.Investigation summary: the sample was returned for evaluation.The returned sample confirmed that the user could not deploy stent.A force transmitting catheter joint was found broken which made a successful deployment impossible.Based on the information available the investigation is closed with confirmed result for break of a force transmitting joint.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant instructions for use the potential issue was found addressed.The instructions for use state: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' in regards to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended'.Under materials required the instructions for use state: '5f (1.67 mm) or larger introducer sheath (¿) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire'.Holding and handling of the system throughout the procedure was found sufficiently described.(expiry date: 06/2023).

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12808082
• MDR Text Key: 281601101
• Report Number: 9681442-2021-00587
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120152
• UDI-Public: (01)00801741120152
• 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: 11/10/2021

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 Model Number: 5F060403CS
• Device Catalogue Number: 5F060403CS
• Device Lot Number: ANET3542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/13/2021
• 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