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

Catalog Number UNK LIFESTENT VASCSTNT SYS

Device Problems Entrapment of Device (1212); Malposition of Device (2616); Patient-Device Incompatibility (2682)

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

Event Date 10/14/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.

Event Description

It was reported in an article that there was localized wall perforation post life stent expansion.There was no reported patient injury.

Event Description

It was reported in an article that after stent placement of lifestent in the subclavian artery with radial access, there was localized wall perforation after post expansion.Malposition and entrapment of device were noted.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a lot history review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not available for evaluation.The article contains images but stent struts are not visible so that a stent deficiency potentially related to the reported issue cannot be identified, therefore the investigation is inconclusive.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describe holding and handling of the system throughout deployment to prevent irregular deployment.A stent size selection table is part of the instructions for use describing the relationship between reference vessel diameter and unconstrained stent inner diameter.In regards to pta the instructions for use state: 'predilitation of the lesion should be performed using standard techniques.While maintaining site access with a guidewire, remove the balloon catheter from the patient.Caution: during dilation, do not expand the balloon such that dissection complication or perforation could occur.' and 'post stent expansion with a pta catheter is recommended.If performed, select a balloon catheter that matches the size of the reference vessel, but that is not larger than the stent diameter itself.' the instructions for use further state: 'recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.' 'intimal injury/dissection' was found mentioned as potential adverse event that may occur.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.

Manufacturer Narrative

H10: manufacturing review: a lot history review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not available for evaluation.The article contains images but stent struts are not visible so that a stent deficiency potentially related to the reported issue cannot be identified, therefore the investigation is inconclusive.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describe holding and handling of the system throughout deployment to prevent irregular deployment.A stent size selection table is part of the instructions for use describing the relationship between reference vessel diameter and unconstrained stent inner diameter.In regards to pta the instructions for use state: 'predilitation of the lesion should be performed using standard techniques.While maintaining site access with a guidewire, remove the balloon catheter from the patient.Caution: during dilation, do not expand the balloon such that dissection complication or perforation could occur.' and 'post stent expansion with a pta catheter is recommended.If performed, select a balloon catheter that matches the size of the reference vessel, but that is not larger than the stent diameter itself.' the instructions for use further state: 'recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.' 'intimal injury/dissection' was found mentioned as potential adverse event that may occur.G.Valenti, n.Scardigno, d.Maiorano, m.Salcuni, et al., (2020).¿experience is the hardest kind of teacher.It gives you the test first and the lesson afterward.¿, european heart journal supplements, 22 (supplement g): g74¿g75.Doi: 10.1093/eurheartj/suaa105 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 in an article that after stent placement of an unknown lifestent in the subclavian artery with radial access, there was localized wall perforation after post expansion.Malposition and entrapment of device were noted.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12792276
• MDR Text Key: 281600848
• Report Number: 9681442-2021-00581
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AL
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

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: 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: 10/14/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 02/28/2022; 06/08/2022
• Supplement Dates FDA Received: 03/02/2022; 06/30/2022
• 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 Sex: Female