MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME US; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number ADM060020130

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During the index procedure one medtronic standard pta was used to treat the left anastomosis.Approx one year post index procedure, it was reported that the patient suffered high grade stenosis in the juxta anastomotic region of the avf.The patient was treated with medication and pci.A non medtronic pta was used to treat the in cannulation zone and the patient was also treated with coil embolization.The patient recovered.The investigator and safety assessed the event as not related to the index device, procedure or paclitaxel.Cec assessed the event as related to the index device and not related to the index procedure or paclitaxel.Cec commented that the pci of the target limb was clinically driven and involved the target lesion.

Manufacturer Narrative

Additional information: lot# of admiral xtreme index device provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME US
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av.paseo del cucapah; #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av.paseo del cucapah; #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8657406
• MDR Text Key: 146621742
• Report Number: 9612164-2019-02107
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: ADM060020130
• Device Lot Number: 210591415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2019
• Date Device Manufactured: 01/06/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR