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

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

Patient Problems Stenosis (2263); Injury (2348); Pseudoaneurysm (2605)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: a systematic review and meta-analysis of randomized controlled trials journal: plos one year: 2020 ref: doi: 10.1371/journal.Pone.0231463 a.Average age.Majority gender.Date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

This article is based on a comprehensive search in the medline, embase, and central databases was conducted in order to identify eligible randomized controlled trials evaluating dcb angioplasty for hemodialysis vascular access dysfunction.The aim of this systematic review and meta-analysis is to assess the patency outcomes following dcb angioplasty, as compared to conventional balloon (cb) angioplasty for the stenosis of hemodialysis vascular access.The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications.Risk ratios (rr) were pooled and relevant subgroups were analyzed separately.Eleven randomized controlled trials comprised of 487 patients treated with dcb angioplasty and 489 patients treated with cb angioplasty were included.There were no significant differences in the target lesion primary patency at 6 months [rr, 0.75; 95% confidence interval (ci), 0.56, 1.01; p = 0.06] and at 12 months (rr 0.89; 95% ci, 0.79, 1.00; p = 0.06).The absence of benefit for the dcb group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis.The risk of procedure related complication did not differ between the two groups (rr 1.00; 95% ci 0.98, 1.02; p =0.95).The occurrence of dissection and pseudoaneurysm is reported to have occurred in the dcb group of the irani study (2018) during a 12 month follow-up period.There is no indication in the literature that the dissection was treated or caused by the inpact admiral device used for treatment.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10533518
• MDR Text Key: 206963667
• Report Number: 9612164-2020-03454
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

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: 08/19/2020
• Initial Date FDA Received: 09/15/2020
• 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: 59 YR