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 Inflammation (1932); Reocclusion (1985); Patient Problem/Medical Problem (2688)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Journal article title: "variants of endovascular revascularization of lower limbs with critical ischemia doe extensive atherosclerosis and assessment of their effectiveness." georgian medical news no 10 (283) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

A retrospective analysis of the results of endovascular operations on the arteries of the lower extremities was performed in 209 patients.An ultrasound examination of arterial vessels was carried out for the examination of the arterial system.Based on clinical and angiographic data, several variants of endovascular revascularization of the lower extremities were used.In 17 patients there was a recoil phenomenon, which required to prevent the early restenosis of stenting of the parotid artery area.In 11 cases (5.3%) subintimal angioplasty was performed based on certain indications.In 17 (8.1%) patients, balloon angioplasty was used using in cylinders.Pact admiral (medtronic inc.Usa) with free pac coating containing urea and paclitaxel.In all cases, this method of angioplasty was used for vasoballoone division of the thigh popliteal area.The evaluation of the results of endovascular surgical interventions was carried out at the discharge of the patient from the hospital, after 3 and 6 months after the operation.It was based on complaints of the patient, on the data of objective examination and ultrasound dopplerography of the arteries with the measurement of the ankle and shoulder index (kpi).Also, in order to assess the state of the microcirculatory bed, a study of partial pressure of oxygen in the surface soft tissues of the lower limb (transcutaneous oximetry) was performed.After analyzing the results of restorative operations, clinical success in the first 6 months was achieved in 171 (81.8%) patients.Among them, a significant improvement in the limb was reported in 94 (45.0%) patients, moderate improvement was noted in 73 (34.9%) patients, unchanged in 26 (12.4%) cases, and a moderate deterioration at 16 (7.7%) patients.At 14th day after the restoration of blood supply, a natural increase in the values of tcpo2 in the vast majority of patients (179 - 85.0%).In the further dynamic observation, the maximum increase in tcpo2 have occurred on 1-2 month.The fluctuations of the tcpo2 levels after endovascular surgery are explained by the presence of postoperative edema of the foot and shin that disappear over time, as well as the probable adaptation of the microcirculation to the restored blood flow.Reperfusion tissue injury and, as a result, local inflammation may be an additional factor in the delayed growth of oxygen tension.Cumulative vascular passage after endovascular operations was: 1st month - 94.5%, 2nd month - 92.3%, 6 month - 87.4%, one year later - 78.1%, in 2 years - 69.8%.The highest frequency of restenosis and reocclusion was noted in the first 6 months.All patients had a successful repeated endovascular reconstruction of the lesion area.Cumulative limb preservation after endovascular surgery was: 1 month- 100%, 2 months - 94.3%, 6 months - 90.6%, in 2 years - 84.1%.

• 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: 8631598
• MDR Text Key: 145762234
• Report Number: 9612164-2019-01889
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: UP
• 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: 05/22/2019

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: 05/15/2019
• Initial Date FDA Received: 05/22/2019
• 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: 67 YR