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); Embolism/Embolus (4438)

Event Type  Injury  

Event Description

Medtronic received an article titled 'treatment of chronic sfa in-stent occlusion with combined laser atherectomy and drug-eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study'.The aim of the study wasto compare the safety and efficacy of laser debulking (ld) and drug-eluting balloon (deb) angioplasty to treatment with deb angioplasty alone in patients affected by critical limb ischemia (cli) and superficial femoral artery (sfa) chronic stent occlusion in a prospective, randomized study.Among 448 cli patients treated from (b)(6)2009 to (b)(6) 2011, 48 patients with chronic sfa in-stent occlusion were randomly assigned to treatment using ld+deb (n=24) or deb angioplasty alone (n=24).Patency at 12 months was the primary outcome measure; secondary outcomes were target lesion revascularization (tlr) and clinical success at 12 months.After debulking with atherectomy, a 4 to 6-mm balloon (admiral; medtronic cardiovascular, santa rosa, ca, usa) was inflated at low p ressure for at least 1 minute, followed by a 5 to 7-mm paclitaxel-coated non-medtronic balloon with a standardized inflation time of 1 minute.Procedural success was obtained in all patients.No adverse events related to ld or the drug coating were recorded in either group.Three patients (4%) ld+deb and 2 (8%) deb only had a local hematoma that resolved spontaneously without further intervention distal embolization occurred immediately in 3 patients (1 ld+deb and 2 deb only); it was treated successfully with thromboaspiration in 2 cases and surgical fogarty thrombectomy in the other.No other adverse events were recorded.In the ld+deb group, the patency rates at 6 and 12 months (91.7% and 66.7%, respectively) were significantly higher than in the deb only patients (58.3% and 37.5%, respectively).Tlr at 12 months was 16.7% in the ld+deb group and 50% in the deb only group.Two (8%) patients needed major amputations in the ld+deb group vs.11 (46%) in the deb only group at 12 months.

Manufacturer Narrative

Treatment of chronic sfa in-stent occlusion with combined laser atherectomy and drug-eluting balloon angioplasty in patients with critical limb ischemia: a single-center, prospective, randomized study j endovasc ther.2013;20:805¿814 a2 - average age a3 - majority gender.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 18777953
• MDR Text Key: 336214361
• Report Number: 9612164-2024-00937
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: 02/19/2024
• 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: 74 YR
• Patient Sex: Male