MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS; 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  

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: (b)(4).Age or dob: average age, sex: majority gender, date of event: 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.

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.Medtronic¿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

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: PACIFIC PLUS
• 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: 13892445
• MDR Text Key: 293149942
• Report Number: 9612164-2022-01161
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K123358
• 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,Followup
• Report Date: 07/06/2022

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• 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: 65 YR
• Patient Sex: Male