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

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

Patient Problems Intimal Dissection (1333); Hematoma (1884); Occlusion (1984); Thromboembolism (2654)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The purpose of the study was to evaluate the efficacy and safety of the ¿percutaneous direct puncture of occluded superficial femoral artery (sfa)¿ technique for recanalization of sfa, after failure of antegraderecanalization in patients with limited access to retrograde popliteal and crural arteries. Between april 2014 and november 2017, 10 patients with cli (critical limb ischemia) underwent endovascular recanalization with direct percutaneous puncture of occluded sfa after failed antegrade recanalization. All patients had a long segment (39,9 ± 2. 8 cm) occluded sfa without stump causing failed antegrade recanalization with a cannulated guidewire in the sfa origin. After unsuccessful attempts with the antegrade approach, the retrograde direct puncture technique of the occluded sfa was performed and followed by antegrade recanalization. Balloon angioplasty was performed over the guidewire distal to the peripheral occluded segments with 5¿6 mm diameter balloons (medtronic, pacific¿ xtreme, usa)]. Stents were placed (ev3 inc. , plymouth, mn, usa) if residual stenosis was n30% or flow-limiting dissection was seen on the control angiography images. In the same session, btk arteries were recanalized with balloons (size range 2¿2. 5 mm). In 1 patient applied with balloon angioplasty at the occluded proximal segment of sfa, there was no flow in the deep femoral artery on the post-procedural control angiography, and this patient had no complaints after the procedure and there was no recurrent occlusion occurred during the follow-up period. In addition to the sfa recanalization, the procedure was also applied to the external iliac artery and cfa in 1 patient, to the popliteal artery in 6 patients and to btk arteries in 10 patients to provide direct blood flow for the foot. Balloon angioplasty was performed all cases and stent placement for sfa occlusion was applied to 4 patients. Of the total 10 patients, 3 (30%) underwent minor amputation afterrevascularization, because of tissue loss in the toes. The mean follow-up period was 25,1 ± 9,6 months. According to the kaplan-meier analysis, the amputation-free survival rate was 60% at 12 and 24 months and the limb salvage rate was 90% at 12 and 24 months the mean procedure time was 101 ± 17,8 min. Recurrent occlusion occurred in 3 patients at 4, 5 and 6 months from the initial procedure and all were successfully treated with conventional antegrade approach.

• Brand Name: PACIFIC XTREME
• 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: 10587832
• MDR Text Key: 208609887
• Report Number: 9612164-2020-03640
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: 09/15/2020
• 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: 09/25/2020 Patient Sequence Number: 1