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

Model Number EX071203CS

Device Problems Loss of or Failure to Bond (1068); Break (1069); Positioning Failure (1158); Premature Activation (1484)

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

Event Date 07/29/2021

Event Type  malfunction  

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: 10/2022).

Event Description

It was reported that during a stent graft placement procedure, the stent allegedly failed to deploy and the housing sheath would not come back to deploy the stent.It was further reported that the stent was deployed in the sheath and the physician decided to remove the system upon removing the deployment system.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure, the stent allegedly failed to deploy and the housing sheath would not come back to deploy the stent.It was further reported that the stent was deployed in the sheath and the physician decided to remove the system upon removing the deployment system.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: 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 to the manufacturer for evaluation.The returned sample confirmed that the stent could not be deployed at the lesion, and that the stent deployed inside the introducer sheath.The sample was found with activated thumb slider and wheel, and the stent was not inside the stent housing as it was found fractured inside the returned introducer sheath.The distal stent end and the system tip were missing, the disposition was not known.During evaluation the system could be further activated but with increased release force probably related to dried/coagulated blood.Although a deployment failure is not visible on the returned sample, the description provided by the user, and the condition of the sample lead to confirmed result for deployment failure and subsequent failure of the tip adhesive joint.In this case the system was used off label, and a long system was used for the ipsilateral retrograde procedure.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 instruction for use state closely describe holding and handling of the system throughout the procedure; in particular the instruction for use state: 'confirm that the introducer sheath is secure and will not move during deployment.(¿) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.Note: do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position.Note: if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit.' in regards to pta the instruction for use state: 'predilation of the lesion should be performed using standard techniques.' the instruction for use further state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035¿ diameter guidewire (¿)', and 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' the lifestent xl vascular stent system is intended to improve luminal diameter (¿) in the native superficial femoral artery (sfa) and popliteal artery (¿).H10: (expiry date: 10/2022).H11: section a through f ¿ the information provide 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 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: 12453009
• MDR Text Key: 270808988
• Report Number: 9681442-2021-00500
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001319
• UDI-Public: (01)04049519001319
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX071203CS
• Device Catalogue Number: EX071203CS
• Device Lot Number: ANEX2042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• 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