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

Catalog Number EX062001JL

Device Problems Premature Activation (1484); Malposition of Device (2616); Material Deformation (2976)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestent solo vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent solo vascular stent system products are identified in d2 and g4.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.Device not returned.

Event Description

It was reported that during the stent placement procedure via an ipsilateral approach, the proximal part of the stent allegedly deployed in the sheath.The stent allegedly elongated when the sheath was removed outside the patient's body because the distal part of the stent still deployed in the vessel.The part of the stent coming out from the sheath was cut by surgically and thereafter sutured.Reportedly, the stent deployed prematurely.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during the stent placement procedure via an ipsilateral approach, the proximal part of the stent allegedly deployed in the sheath.The stent allegedly elongated when the sheath was removed outside the patient's body because the distal part of the stent still deployed in the vessel.The part of the stent coming out from the sheath was cut by surgically and thereafter sutured.Reportedly, the stent deployed prematurely.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 solo vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent solo vascular stent system products are identified in d2 and g4.H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was not available for evaluation.A series of ct images was provided, but the deployed stent or delivery system were not visible in detail.An x-ray was provided demonstrating the placed stent in the sfa, but the proximal stent end is not displayed so that a length measurement is not possible.The resolution is poor so that a detailed strut evaluation is not possible.The intended placement site was not reported.The investigation leads to inconclusive result for premature deployment and the reported cascading issues.The guidewire was reported running smoothly inside the system.Reportedly there was no difficulty advancing which may indicate an issue potentially related to safety slider activation.Based on the information available, the investigation is closed with inconclusive result.The reported premature deployment could not be confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: review of the relevant labeling was conducted, and the potential issue was found addressed.The instructions for use states: "ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed." regarding pta the instructions for use states: "predilation of the lesion should be performed using standard techniques." the instructions for use further states: "if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used." and "verify that the safety lock slider is still in the locked position." regarding accessories the instructions for use states: "gain femoral access utilizing a 6 fr (2 mm) or larger introducer sheath"' the instructions for use describes unlocking of the safety slider straight before deployment.H10: d4 (expiry date: 11/2022).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 SOLO 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: 15830882
• MDR Text Key: 305586632
• Report Number: 9681442-2022-00333
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/13/2022

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: EX062001JL
• Device Lot Number: ANEY4280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/19/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/19/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Female