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

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

Patient Problems Unspecified Infection (1930); Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Event date: date of article publication arteriovenous fistula formation with adjuvant endovascular maturation journal of vascular surgery (2021) 10.1016/j.Jvs.2021.08.072.If information is provided in the future, a supplemental report will be issued.

Event Description

The study reports 82 consecutive patients with incident end-stage renal disease (esrd) undergoing avf formation with early adjuvant endovascular treatment demonstrated a mean time to maturation of 67.8 +/- 65.9 (5-320) days with 93.9% of avfs mature by 6 months.The early endovascular assisted maturation program was established after the formation of a multidisciplinary renal vascular clinical service in 2014.All patients who were referred for their first avf as they were considered long term dialysis candidates were considered for inclusion.Patients were referred to the renal vascular clinic when the estimated glomerular filtration rate (egfr) was less than 20mm/min/1.73m2, and the patient was deemed a long-term hemodialysis candidate by the attending nephrologist.Patients were assessed by a vascular access nurse specialist and vascular surgeon, with ultrasound mapping of the upper limb veins and arteries performed after application of a light upper arm tourniquet.Avf endovascular interventions were performed by a single attending vascular surgeon after administration of local +/- regional +/- general anesthesia.The type of endovascular intervention selected, was based on the underlying pathology as well as the urgency and need for hemodialysis.Avfs with a juxta-anastomotic stenosis (jxas) would generally undergo angioplasty with plain balloon or drug coated balloon (inpact admiral) in the first instance, however stenting was adapted as a first line strategy in the latter years of the study.Post procedural and post avf formation adverse events reported for this study are infection treated with antibiotics, avf occlusion with stenosis formation, death and thrombosis.There is no established or suspected causal relationship between the device(s) and the death events.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12785795
• MDR Text Key: 280609463
• Report Number: 9612164-2021-04318
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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: 10/25/2021
• 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: 63 YR
• Patient Sex: Male