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

Catalog Number EX061201C

Device Problem Material Deformation (2976)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent xl vascular stent system products that are cleared in the us.The pro code and 510k number for the lifestent xl vascular stent system products is 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).Device not returned.

Event Description

It was reported that during stent placement procedure, the stent allegedly elongated.There was no reported patient injury.

Event Description

It was reported that during stent placement procedure, the stent allegedly elongated.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 xl vascular stent system products that are cleared in the us.The pro code and 510k number for the lifestent xl vascular stent system products is 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 physical sample was not available for evaluation; one provided image demonstrates two overlapping stents inside the sfa.Only the stent in proximal position is visible over the entire length.Resolution is poor so that a stent strut structure evaluation for elongation is not possible.A software scale is part of the image but an elongation cannot be identified.The investigation leads to inconclusive evaluation result.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.Holding and handling of the system throughout deployment was found sufficiently described, in particular the instructions for use state: 'remove slack from the delivery system catheter held outside the patient.(.) 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 not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.' in regards to pta the instructions for use state: 'predilitation of the lesion should be performed using standard techniques.' the instructions for use further state: 'cases of fracture have been reported (.) in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at deployment.Therefore, care should be taken when deploying the stent as manipulation of the delivery system may (.) lead to stent elongation and subsequent stent fracture.' in regards to accessories the instructions for use state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire (.)' h10: d4 (expiry date: 05/2023), g3 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.H3 other text : device not returned.

• Brand Name: LIFESTENT XL 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: 12850668
• MDR Text Key: 281077593
• Report Number: 9681442-2021-00601
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001456
• UDI-Public: (01)04049519001456
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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: EX061201C
• Device Lot Number: ANFS2247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 04/25/2022
• 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