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 Diarrhea (1811); Hematoma (1884); Nausea (1970); Pain (1994); Vomiting (2144); Restenosis (4576)

Event Date 11/16/2021

Event Type  Injury  

Event Description

A journal article was submitted detailing a study to assess the feasibility and safety of hybrid angiography consisting of carbon di oxide (co2) angiography supplemented by small doses of iodinated contrast medium (icm) in the endovascular treatment of chronic limb threatening ischemia (clti) patients with pre-existing chronic kidney disease (ckd). 206 patients were included in the study. Medt ronic¿s trailblazer support catheter was used in combination with other guidewires for crossing lesions. After crossing the lesion, plain balloon angioplasty was completed using medtronic¿s 0. 035 admiral xtreme balloon and/or 0. 018 pacific plus balloon. Stenting was reserved for residual stenosis
=
30% or flow-limiting dissection. Hemostasis of the access site was done by manual compression. Technical success was defined as restoration of inline flow to the foot with <(><<)>30% residual stenosis. Perioperative morbidity and mortality, defined as complications and death occurring within 30 days following the procedure. Long-term outcomes measured included assisted primary patency, defined as patency maintained with the use of an additional surgical or endovascular procedures as long as occlusion of the primary treated site has not occurred; secondary patency, defined as patency obtained with the use of an additional procedures after occlusion occurs; clinically driven¿target lesion revascularization (cdtlr), defined as any re-intervention at the target lesion(s) due to symptoms or drop of abi of
=
20% or >. 15 when compared to post-procedure baseline abi; and amputation-free survival (afs), defined as time until a major (above-ankle) amputation of the index limb or death from any cause. Technical success was achieved in 95. 6% of cases. Technical failures occurred in nine patients due to either inability to cross the lesion (5 patients) or failed re-entry into the true lumen during subintimal recanalization (4 patients). All nine failures received subsequent bypass surgery that were successful in 8 patients and failed in one patient who underwent a later below-knee amputation. No deaths or major systemic complications (stroke or myocardial infarction) occurred within 30 days of the procedure. One patient received a major amputation after failed endovascular and a subsequent open surgical attempt for revascularization. None of the patients suffered from respiratory or neurological complications. Other noted complications included access site hematoma (10 patients), transient abdominal pain (6 patients, 2. 9%), nausea (5 patients), vomiting (2 patients), and diarrhoea (2 patients). Procedural outcomes for the population included major amputation (11. 7%), and death (6. 8%). Primary patency reported as 64. 5 +/- 3. 5% at 12 months. Freedom from cd-tlr reported as 74. 7 +/- 3. 1% at 12 months. Amputation free survival reported as 81 +/- 2. 8% at 12 months. There is no established or suspected causal relationship between the device(s) and the death events.

Manufacturer Narrative

Title: safety and efficacy of hybrid angiography in chronic lower extremity ischemia patients at risk of contrast-induced acute kidney injury author: ashraf g. Taha, mahmoud saleh, haitham ali journal: vascular and endovascular surgery year: 2022 vol/issue: 56 (2) ref: 10. 1177/15385744211055908. Average age, majority gender, date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events. Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product. Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device. If information is provided in the future, a supplemental report will be issued.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13892357
• MDR Text Key: 293152460
• Report Number: 9612164-2022-01160
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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
• Date Manufacturer Received: 03/15/2022
• 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: 03/24/2022 Patient Sequence Number: 1