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 Occlusion (1984); Thrombus (2101); Stenosis (2263)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

Average age of patients, sex: larger number of gender, event date: date of publication article title: a randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts journal of vascular surgery 2019 0741-5214 copyright _ 2019 by the society for vascular surgery.Published by elsevier inc.Https://doi.Org/10.1016/j.Jvs.2019.07.090.If information is provided in the future, a supplemental report will be issued.

Event Description

Patients in the dcb group of study have a history of hypertension and previous peripheral revascularization.During procedure of dcb group, in.Pact admiral paclitaxel eluting balloon catheters were used to treat the prosthetic grafts of patients with avf dysfunction undergoing dialysis.There were 44 patients randomized to the study with 22 in the dcb (drug-coated balloon) group and 22 n the cb (conventional balloon) group.Within the 1-year follow up, one patient death was reported.In the article, it was indicated that the death not related to use of device.It was reported that in 6 cases target lesion restenosis occurred and treated with revascularization.Thrombotic occlusion were noted in the dcb group.Objective paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (av) fistulas.However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts.We aimed to compare the efficacy of angioplasty with drug-coated balloons (dcbs) and angioplasty with conventional balloons (cbs) for venous anastomotic stenosis in dysfunctional av grafts.Methods in this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with dcbs (n = 22) or cbs (n = 22) from july 2015 to august 2018.Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions.The primary end point was target lesion primary patency at 6 months.Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year.Results at 6 months, target lesion primary patency in the dcb group was significantly greater than that in the cb group (41% vs 9%; hazard ratio [hr], 0.393; 95% confidence interval [ci], 0.194-0.795; p =.006), as was the primary patency of the entire access circuit (36% vs 9%; hr, 0.436; 95% ci, 0.218-0.870; p =.013).At 1 year, the target lesion primary patency in the dcb group remained greater than that in the cb group (23% vs 9%; hr, 0.477; 95% ci, 0.243-0.933; p =.019) but not the primary patency of the access circuit (14% vs 9%; hr, 0.552; 95% ci, 0.288-1.059; p =.056).No difference in anatomic or clinical success was observed; no major complications were noted.All patients completed clinical follow-up for 1 year.The 1-year target lesion intervention-free intervals were 175.2 6 131.3 days in the dcb group and 85.2 6 100.4 days in the cb group (p ¼.015).The 1-year access circuit intervention-free intervals were 152.8 6 118.2 days in the dcb group and 85.2 6 100.4 days in the cb group (p ¼.047).The frequencies of reintervention within 12 months were 2.7 times in thedcb group and 4.4 times in the cb group, respectively (p ¼.065; table iii; fig 2).In the dcb group, reinterventions within 12 months included 8 balloon angioplasties for non-target lesion stenosis (2 cases) and target lesion restenosis (6 cases) and 11 thrombectomies for thrombosis of access circuits.In the cb group, reinterventions included 13 balloon angioplasties for target lesion restenosis and 7 thrombectomies for thrombosis of access circuits.More thrombotic occlusions were noted in the dcb group than in the cb group, but the difference did not reach statistical significance (50% vs 31.8%; p ¼.22; table iii) conclusions angioplasty with dcbs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis av grafts at 6 months.The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.

• 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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9390444
• MDR Text Key: 168586354
• Report Number: 9612164-2019-04942
• 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: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• 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: 11/15/2019
• 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: 70 YR