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

Catalog Number EX061703JL

Device Problems Malposition of Device (2616); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was not returned to the manufacturer for review.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.The catalog number identified 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 pro code for the lifestent solo vascular stent system products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model ex061703jl vascular stent experienced malposition of the device.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and gender were not provided for the patient.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model ex061703jl vascular stent experienced malposition of the device and material deformation.This information was received from one source.One patient was involved with no patient consequences.The 76 year old male patient was 72 kgs.

Manufacturer Narrative

H10: the lot number for the device was provided; therefore, a lot history review was performed.The device was not returned to the manufacturer for 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 device is labeled for single use.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 pro code for the lifestent solo vascular stent system products is identified in d2.Masato nakamura, michael r.Jaff, richard a.Settlage, and kimihiko kichikawa (2018).Nitinol self-expanding stents for the treatment of obstructive superficial femoral artery disease: three-year results of the reliable japanese multicenter study.Ann vasc dis vol.11, no.3; 2018; pp 324¿334.Doi: 10.3400/avd.Oa.18-00067.H10: g3, h6(device).H11: b5, g1, h6(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.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 9940028
• MDR Text Key: 187388777
• Report Number: 9681442-2020-00081
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741110399
• UDI-Public: (01)00801741110399
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: EX061703JL
• Device Lot Number: ANXA4030
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Type of Device Usage: A
• Patient Sequence Number: 1