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 Thrombosis (2100)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Aim: dysfunctional arteriovenous (av) access remains a significant cause of morbidity and hospital admission for patients with end stage renal failure on haemodialysis.This study was performed to evaluate the impact of paclitaxel-coated balloon (pcb) on the patency of av access with recurrent stenoses.Within this retrospective study the impact adrmiral drug-coated balloon was used.Methods: we retrospectively studied haemodialysis patients who presented to our centre with recurrent av access dysfunction and compared intervention-free patency using plain balloon versus pcb.Results: a total of 147 patients were followed up longitudinally.Intervention-free patency was better following pcb compared to previous intervention using plain balloons (6.4 5.8 versus 4.0 3.7, p <(><<)> 0.01).The 3- and 6-month patency rates after pcb were significantly better compared to standard plain angioplasty balloon: 69.4% versus 52.4%, p <(><<)> 0.01 and 42.9% versus 15.6%, p <(><<)> 0.01 respectively.Kaplan¿meier survival analysis of circuit patency demonstrated the superiority of pcb over plain balloon angioplasty in both arteriovenous fistula and arteriovenous graft (p <(><<)> 0.01 and p = 0.01 respectively) although the patency of arteriovenous fistula remained significantly better than arteriovenous graft following interventions with pcb (p <(><<)> 0.01).Age of av access and the number of previous interventions were found to be significant predictors of patency following pcb intervention.Conclusion: arteriovenous access intervention with pcb was shown to be superior compared to plain balloon in the treatment of both nonthrombosed and thrombosed av accesses in our multi-ethnic population.

• 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: 9502416
• MDR Text Key: 189004544
• Report Number: 9612164-2019-05260
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2019

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: 12/10/2019
• Initial Date FDA Received: 12/20/2019
• 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: 62 YR