MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS

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

Patient Problems Vascular Dissection (3160); Gastrointestinal Hemorrhage (4476)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Impact of intravascular ultrasound parameters and platelet reactivity on primary patency after drug-coated balloon angioplasty for femoropopliteal artery disease heart and vessels (2023) 38:497¿506 https://doi.Org/10.1007/s00380-022-02201-0 a2 - average age.A3 - majority gender b3 - date of publication 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a literature article titled 'impact of intravascular ultrasound parameters and platelet reactivity on primary patency after drug-coated balloon angioplasty for femoropopliteal artery disease'.All treatment decisions including dcb use or additional devices were driven by the operator¿s discretion.All of the patients were treated with in.Pact admiral pcb (medtronic, minneapolis, minnesota).A total of 160 patients and 213 lesions were included in the registry.No provisional stenting was reqrueid during procedures.Dissections pst procedure were type a n= 69, type b n=58, type c n=22, type d n=12 and type e n=1.The cumulative incidence of all-cause death was 6.6% at 12 months.Within 30 days of the index procedure, only 1 death occurred, which was due to liver abscess in a patient treated for rutherford class 5 in clti.Within 3 months, 2 patients died due to septic shock caused by wound infection and another patient died due to acute renal failure.Other deaths occurred more than 3 months after treatment due to cancer, multiple organ failure, gastrointestinal bleeding or cerebral hemorrhage.Primary patency by kaplan¿meier estimate was 92.6% at 6 months and 79.2% at 12 months for the entire study cohort and freedom from tlr was 95.1% at 6 months and 89.1% at 12 months.All patients undergoing intervention exhibited clinical symptoms, and tlrs were considered clinically driven.Freedom from all-cause death was 96.1% at 6 months and 93.4% at 12 months.Freedom from bleeding events was 98.1% at 6 months and 97.4% at 12 months.There were no major target limb amputations through 12 months.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16902273
• MDR Text Key: 314905036
• Report Number: 9612164-2023-01963
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/10/2023
• 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 Age: 75 YR
• Patient Sex: Male