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

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

Patient Problems Hematoma (1884); Rupture (2208); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Restenosis (4576)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A journal article was submitted detailing a retrospective single-center study to evaluate efficacy of percutaneous transluminal angioplasty (pta) for the endovascular management of arteriovenous fistula (avf) dysfunction in patients with end-stage renal disease (esrd). 135 patients were included in the study who underwent endovascular treatment for a dysfunctional native avf. Medtronic¿s standard pta balloons (4-9mm) were used during the procedure to treat avf dysfunction. The balloon was maintained inflated for 2 minutes, and the procedure was repeated if necessary. Pta was technically successful in 100. 0% of operations, with residual stenosis (>30%) in 5. 2% of patients. Pta revealed clinical success in terms of adequate dialysis after the procedure in 97. 0% of patients, with complications only in 7. 4%. Complications reported include vasospasm (7 patients), ad hematoma (2 patients). Rupture is reported in 1 patient. During the follow-up period of 6 months the avf remained patent in 94 patients (median primary patency duration of 5. 0 months). Dysfunction recurrence reported in 41 patients, restenosis (7 patients) and occlusion (34 patients).

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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 ; EI ; 091708734
• MDR Report Key: 12121604
• MDR Text Key: 260044632
• Report Number: 9612164-2021-02626
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K062809
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• 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: 06/23/2021
• 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: 07/06/2021 Patient Sequence Number: 1