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 Problem Occlusion (1984)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Journal title: a retrospective comparison analysis of results of drug-coated balloon versus plain balloon angioplasty in treatment of juxta-anastomotic de novo stenosis of radiocephalic arteriovenous fistulas journal: the journal of vascular access year: 2020 ref: doi: 10.1177/1129729819893205.If information is provided in the future, a supplemental report will be issued.

Event Description

This journal article was published to report a retrospective analysis of 80 patients with a juxta-anastomotic stenosis of distal radiocephalic arteriovenous fistula between january 2016 and september 2017.Patients were divided into two groups according to the type of treatment as drug-coated balloon ¿ percutaneous transluminal angioplasty (n = 44) and plain balloon ¿ percutaneous transluminal angioplasty (n = 43).Intra- and post-procedural data were recorded.Both groups had mature fistulas, and the mean age of fistula was 11.3 ± 9.1 months in the drug-coated balloon ¿ percutaneous transluminal angioplasty group and 10.3 ± 8.8 months in the plain balloon ¿ percutaneous transluminal angioplasty group.A non-medtronic balloon was used for the plain balloon group and in.Pact admiral was used as the dcb of choice for the treatment of the dcb group.Acetylsalicylic acid (100 mg/day) was prescribed in both gro ups after the procedure.Routine follow-up was performed with cdus at 3, 6, 9, and 12 months, and target lesion primary patency (tlpp) was evaluated.There was no significant difference in the target lesion stenosis rate and the median lesion length between the groups.Baseline demographic and clinical characteristics of the patient groups are shown in table 1.Technical and clinical success were achieved in both groups.Although tlpp was similar at 6 months between the groups (93.1% vs 81.3%, respectively; p = 0.14), the dcb-pta group had significantly higher rates at 12 months (81.8% vs 51.1%, respectively; p = 0.01) (table 2).During follow-up, 8 patients in the dcb-pta group and 21 patients in the pb-pta group required reintervention due to target lesion-related stenosis.The kaplan¿meier plot showed a statistically significant difference in the tlpp rates between the group.No further injury is reported.

• 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: 10573392
• MDR Text Key: 208130113
• Report Number: 9612164-2020-03575
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 09/23/2020

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: 09/15/2020
• Initial Date FDA Received: 09/23/2020
• 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: 56 YR