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

Catalog Number EX061001C

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Material Deformation (2976); Difficult or Delayed Separation (4044)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2023).

Event Description

It was reported that during a recanalization procedure in the femoro poplite, the stent allegedly failed to deploy due to stent foreshortening.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 vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent are identified in d2 and g4.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 delivery system is not available for evaluation.The stent remains implanted.An x-ray image was provided for evaluation, showing multiple stents placed in the femoral artery.Even though there is a section that was flagged with "lifestent 6x100mm" a reported stent foreshortening, malposition or any other stent deficiency could not be verified.The lesion was pre dilated and device compatible accessories were used.However, the tracking path was reported being calcified and a force increase was felt during deployment.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product the potential risk was found addressed.The instructions for use states: "prior to stent deployment, remove slack from the delivery system catheter outside the patient.If excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit." correct stent deployment was found properly described.The instructions for use states: "verify that the distal and proximal stent radiopaque markers are distal and proximal to the target lesion.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 note hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment." regarding preparation and pre dilation the instructions for use states: "gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.(.) insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate length (.) across the lesion to be stented via the introducer sheath.Predilation of the lesion should be performed using standard technique." h11:section a through f - the information provided by bd represents all of 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 femoro-popliteal recanalization procedure the stent allegedly failed to deploy due to stent foreshortening.It was further reported that resistance was felt during the stent deployment and the stent became malpositioned.The procedure was completed using additional stent.There was no reported patient injury.

• 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: 12717281
• MDR Text Key: 279303520
• Report Number: 9681442-2021-00570
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001432
• UDI-Public: (01)04049519001432
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061001C
• Device Lot Number: ANFS2096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• 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