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 Unspecified Infection (1930); Stenosis (2263)

Event Date 08/07/2023

Event Type  Injury  

Event Description

Medtronic received a literature article titled 'a prospective multicenter randomized controlled trial for comparing drug-coated and conventional balloon angioplasty in venous anastomotic stenosis of hemodialysis arteriovenous grafts'.To evaluate the efficacy and safety of drug-coated balloon angioplasty compared to conventional balloon angioplasty in the treatment of dysfunctional arteriovenous grafts.Angioplasty was performed using a 7 mm conventional pta balloon (fortrex pta balloon catheter, medtronic, minneapolis, mn, usa) with an inflation time of 1 min.The balloon length was 4 cm.If the balloon waist was not effaced, we performed a post-balloon angioplasty using a high-pressure balloon (non-medtronic).A special balloon (cutting balloon, scoring balloon) was not used, and patients with [(b)(4) residual stenosis, dissection, or rupture requiring additional treatment after pta were excluded.The pre-dilation pta balloon must be shorter than the dcb length to avoid geographical miss.Patients with successful pre-dilation pta were randomized to undergo either dcba or cba.According to the randomization, secondary pta was performed for 3 min at 7 atm in the same place.Repeat fistulography was performed after the second pta to confirm the final fistulography result.The cba group used the same pre-dilation pta balloon, while the dcba group used a balloon with a length of 6 cm and diameter of 7 mm (in.Pact admiral paclitaxel-coated pta balloon catheter, medtronic).No medications were prescribed after the procedure.Unsuccessful pre-dilation resulting in rupture requiring treatment occurred in 2 case.Residual stenosis (b)(4) after pre-dilation occurred in 2 cases.There were no procedure related complications.The tlpp (target lesion primary patency ) at 3 and 6 months (dcba, (b)(4) and (b)(4); cba, (b)(4) and (b)(4)).The tlpp at 12 months(dcba, (b)(4); cba, (b)(4)) and acpp (access circuit primary patency) at 6 and 12 months (dcba, (b)(4) of the patients with dcba required retreatment within 6 months.Thrombosis post proceure was reported in dcb n=55 and cba n= 57.Other evetns reported during follow up included surgery (infection), surgery (steal) and pseudoaneurysm.Two deaths occurred during the 12-month follow-up (dcba, 1; cba, 1), both were related to heart disease.

Manufacturer Narrative

Literature title a prospective multicenter randomized controlled trial for comparing drug-coated and conventional balloon angioplasty in venous anastomotic stenosis of hemodialysis arteriovenous grafts j endovasc ther 2006;13: 12-22 springer science+business media, llc, part of springer nature and the cardiovascular and interventional radiological society of europe (cirse) 2023 cardiovasc intervent radiol https://doi.Org/10.1007/s00270-023-03536-5 a2 average age a3 majority gender b3 date of acceptance.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: 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: 18364844
• MDR Text Key: 331000321
• Report Number: 9612164-2023-06107
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 12/15/2023
• 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: 65 YR
• Patient Sex: Male