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

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

Medtronic received a literature article titled 'patency of drug-coated versus conventional balloon angioplasty for hemodialysis access stenosis'.The retrospective study included 24 patients with end-stage renal disease, who developed dysfunctional avf during hemodialysis, and underwent endovascular treatment using conventional balloon angioplasty (cba) and drug-coated balloon angioplasty(dcba) from (b)(6) 2014, to (b)(6) 2021.Sixteen men and 8 women with an average age of 63.9 ± 14.2 years, who underwent 333 endovascular treatments in 57 target lesions of access were enrolled.In cases with a history of early significant restenosis of target lesion, a cba was first performed, which was followed by a dcba if the residual stenosis of the target lesion was <(><<)>30% a drug-coated balloon catheter (in.Pact¿ admiral¿, medtronic, mn, usa) was inflated up to a normal pressure of 8 atmospheres and retained for three minutes.A post drug-coated balloon angiogram was performed to evaluate its patency and any complications.For the central vein lesion cba was performed in significant stenotic target lesions with a two-minute retention of the fully expanded balloon.Dcbas in the central veins were performed after a cba in cases of early significant restenosis, using 12- (in.Pact¿ admiral¿, medtronic, mn, usa) or 14-mm (non-medtronic) balloon catheters procedural success was found in 333 procedures (100%).Two minimal cases of minimal contrast leakages were reported.

Manufacturer Narrative

Please reference: anukanchanavera t, hongsakul k, janjindamai p, akkakrisee s, bannangkoon k, rookkapan s, boonsrirat u, geater s.Patency of drug-coated versus conventional balloon angioplasty for hemodialysis access stenosis.Journal of the belgian society of radiology.2023; 107(1): 99, 1¿6.Doi: https://doi.Org/10.5334/jbsr.3315 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18980840
• MDR Text Key: 339272538
• Report Number: 9612164-2024-01458
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• 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