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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Renal Failure (2041); Rupture (2208); Obstruction/Occlusion (2422); Embolism/Embolus (4438)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

A2: average age a3: majority sex literature ref: doi.Org/10.1186/s42155-023-00390.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.

Event Description

Medtronic received a literature article title 'application of first-generation high and low-dose drug-coated balloons to the femorop opliteal artery disease: a sub-analysis of the popcorn registry'.The study used a clinical database of the prospective multicenter registry of drug-coated balloon for femoropopliteal disease (popcorn).Popcorn is an ongoing prospective multicenter observational study that registered adult patients (aged=20 years) undergoing dcb treatment for femoropopliteal lesions of symptomatic peripheral artery disease (rutherford categories 2¿5) [8] at 81 cardiovascular centers across japan.Among 2507 patients undergoing fpa evtwith dcb for symptomatic lead, 602 patients were treated with lowdose non-medtronic dcb, and the remaining 1905 patients were treated with in.Pact admiral high-dose dcb.There were no differences in patient/lesion characteristics, procedural success rates, or complications between the two groups.Perioperative outcomes for the in.Pact admiral high-dose dcb included normal blood flow after dcb (95.8%), dissection grade d or severer (4.1%), bailout stenting (3.1%), perioperative complication(s) (4.8%), target lesion revascularization (evt) (0.9%), target lesion revascularization (bypass) (0.1%), distal embolism (1.0%), transfusion for bleeding (0.5%), acute occlusion (0.1%), vessel rupture (0.1%), blue toe syndrome (0.1%), major amputation (0.4%), myocardial infarction (0.1%), stroke (0.1%) and renal impairment (0.3%).The high dose dcb group had 86.2% freedom from restenosis and 92.5% freedom from reintervention.

• 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: 17927177
• MDR Text Key: 325569468
• Report Number: 9612164-2023-04632
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2023

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
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/12/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male