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

Catalog Number UNK LIFESTENT VASCSTNT SYS

Device Problem Fracture (1260)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.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.

Event Description

It was reported that approximately two months post stent placement procedure in superficial femoral artery, radiography indicated that the stent was allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that sometime post stent placement procedure in superficial femoral artery, radiography indicated that the stent was allegedly ruptured.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was not returned for evaluation.Two images were provided with poor resolution for both tied complaints; the relation of the stents placed to the two complaints is not clear.The images demonstrate a long segment of a stented vessel; it is not clear how many stents have been placed; however at least two stents could be identified, whereas one of the stents is not a lifestent xl.In one section an irregularity is visible; due to poor resolution a closer description is not possible.The investigation leads to inconclusive evaluation result.Therefore, based on the investigation of the provided information, the investigation is closed as inconclusive.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.The instruction for use closely describe holding and handling of the system for regular deployment, in particular the instruction for use state: 'confirm that the introducer sheath is secure and will not move during deployment (.) firmly hold the black system stability sheath throughout deployment.(.) do not hold the silver stent delivery sheath (.) do not constrict the stent delivery sheath during stent deployment.' in regard to pta the instruction for use state: 'predilation of the lesion should be performed using standard techniques.', and 'post stent expansion with a pta catheter is recommended.' in regard to access and accessories the instruction 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 (.)'.Stent fracture was found mentioned as a potential adverse event that may occur; the instruction 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, in rare instances, lead to stent elongation and subsequent stent fracture.' h10: g3 h11: b5, h6 (method, result, conclusion) 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 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: 17124134
• MDR Text Key: 317121683
• Report Number: 9681442-2023-00230
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/05/2023

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: UNK LIFESTENT VASCSTNT SYS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/10/2023
• 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