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

Model Number EX062003CL

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

No medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient with history of dry gangrene and total occlusion of the right superficial femoral artery was scheduled for vascular intervention.Two stents were placed and there was no reported complication.Approximately one week post hospital admission, the patient was right critical limb ischemia required amputation.The right common femoral artery was accessed and an arteriography demonstrated 4cm occlusion of the left superficial femoral artery.The decision was made to place a stent in the left superficial femoral artery prior to right below the knee amputation.Hemostasis was achieved and the patient was transported in stable condition.(08/2018).

Event Description

It was reported through the results of a clinical trial, that approximately one month post angioplasty procedure in the distal superficial femoral artery (sfa) with a focused force percutaneous transluminal angioplasty (pta) balloon, the patient had two vascular stents placed in the right sfa for total occlusion.Approximately one week post vascular stent placement, the patient underwent right below the knee amputation due to dry gangrene and critical limb ischemia.The vascular stents were stenosed at the time of the amputation.The current patient status was not provided.

Event Description

It was reported through the results of a clinical trial, that approximately one month post angioplasty procedure in the distal superficial femoral artery (sfa) with a focused force percutaneous transluminal angioplasty (pta) balloon, the patient had two vascular stents placed in the right sfa for total occlusion.Approximately one week post vascular stent placement, the patient underwent right below the knee amputation due to dry gangrene and critical limb ischemia.The vascular stents were stenosed at the time of the amputation.The current patient status was not provided.

Manufacturer Narrative

Manufacturing review: the lot records have been 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: as no x-ray images were provided the reported in stent restenosis could not be verified.An alleged device relation could not be determined.Based on the information available the investigation will be completed with inconclusive result.Based on the information available a definite root cause for the event reported could not be identified.Labeling review: in reviewing the current version of the labeling supplied with this product, it was found that the ifu sufficiently addresses the potential risk.The ifu states that 'arterial occlusion/restenosis of the treated vessel' as well as 'amputation' are potential adverse events that may occur.Based on the ifu predilation of the lesion should be performed using standard techniques; post stent expansion with a pta catheter is recommended.

• 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
• MDR Report Key: 8200872
• MDR Text Key: 131585160
• Report Number: 9681442-2018-00223
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2020
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANCV2551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR
• Patient Weight: 58