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

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

Patient Problems Occlusion (1984); Thrombus (2101); Stenosis (2263); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average age. Sex: majority gender. Event date: date of article. Publication duplex-guided versus conventional percutaneous transluminal angioplasty of iliac tasc ii a and b lesion: a randomized controlled trial annals of vascular surgery (2019) 55: 138¿147 10. 1016/j. Avsg. 2018. 07. 047. If information is provided in the future, a supplemental report will be issued.

Event Description

This article evaluates whether doppler ultrasound (duplex)-guided pta (dupta) is as effective as an alternative for chronic kidney disease patients as conventional pta in the treatment of iliac arterial stenotic disease due to the possibility of contrast-induced nephropathy after utilization of contrast (nephrotoxic). Patients were randomized in a 1:1 ratio and treated with either dupta (dupta group) or conventional pta (control group) based on computer-generated random numbers. 70 patients were assigned to the pta group with 80 limbs treated, and 72 patients were assigned to the dupta group with 85 limbs treated. Admiral xtreme pta balloons and scuba renal stent systems were among those chosen. Balloon diameters, stent sizes, and length were selected based on stenotic segment measurements utilizing duplex. Under duplex visualization, pta balloons were inflated using an inflation device and stents deployed. To exclude any potential distal embolization the infrapopliteal arterial segment was examined using duplex. Manual compression was applied for at least 10 min after removal of the endovascular materials. The puncture wound was dressed in compression bandage. The dupta group showed a technical success rate of 96. 5%, whereas the conventional pta group had 98. 8% success rate. Complication rate in the conventional pta group was 3, whereas the dupta group had 5 complications. None of the complications were correlated with the imaging technique, but rather with the pta procedure itself. Complications within the pta group are reported as dissection evident after 30 days post-op, not flow limiting, dissection + thrombus of the common femoral artery requiring urokinase treatment, and stenosis of the common femoral artery due to closure device pta. Complications within the dupta group are reported as: pseudoaneurysm of the common femoral artery, luxated atheroma of the common femoral artery requiring embolectomy, acute occlusion requiring cerab procedure, stenosis of the common femoral artery due to closure device, dissection of the common femoral artery requiring endarterectomy). A total of 12 reinterventions were required in the dupta group (8 within the first year), and 6 in the pta group (4 within the first year). Within the first year after intervention 4 patients died, 2 in each intervention group. None of the mortalities were related to the intervention or to the development of renal failure.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8810441
• MDR Text Key: 151705053
• Report Number: 9612164-2019-02964
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/22/2019 Patient Sequence Number: 1