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 Pulmonary Embolism (1498); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Asystole (4442)

Event Date 11/27/2020

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 comparison between patients with high-risk pulmonary embolism (pe) treated with catheter-directed intervention (cdi) plus anticoagulation and patients treated with anticoagulation (ac) only as used before the cdi technique was available.The main predefined outcomes of interest were survival to 90 days and reduction of rv/lv ratio.22 patient¿s were included in the cdi group and 23 in the ac group.Medtronic¿s admiral xtreme was identified as a non-compliant balloon used for initial mechanical fragmentation.14 of the 22 patient¿s in the cdi group were treated with a balloon catheter.Three eligible patients were excluded because the scheduled treatment by cdi was never initiated; two of them improved hemodynamically prior to the intervention, which was consequently inhibited, and one patient succumbed due to circulatory shock before the start of the intervention.Two patients were subjected to surgical thrombectomy due to recurrent pe shortly after cdi; one of them died after 10 days and the other one was still alive after one year.One patient reacted to rheolytic fragmentation with an episode of asystole and another patient displayed repeated bouts of hypotension due to failing right heart performance.No bleeding complications occurred.No patient received rescue thrombolysis after the completed cdi.The procedure was classified as clinically successful in all except three patients who succumbed to circulatory shock unrelated to the intervention and in two patients who died due to irreversible shock in the icu within a few hours after the intervention.Ninety-day survival was 59% after cdi.Among the nine non-survivors in the cdi group, causes of death were pe in eight and cerebral infarction with herniation in one patient.There is no established or suspected causal relationship between the device(s) and the death events.

• 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: 12197298
• MDR Text Key: 262474811
• Report Number: 9612164-2021-02797
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• 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: 70 YR