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 Reocclusion (1985); Injury (2348)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication clinical outcomes differ after femoropopliteal artery treatment between individual paclitaxel-coated balloons journal of vascular surgery (2020) 72(1):e140-e141 10.1016/j.Jvs.2020.04.248.If information is provided in the future, a supplemental report will be issued.

Event Description

This abstract presents a retrospective review of 1165 consecutive patients who underwent femoropopliteal artery intervention by angioplasty, atherectomy, stent placement, or combination and compares 4-year outcomes between patients treated with paclitaxel (ptx)-coated and pobas.The patients were divided into groups based on type of balloon used: poba, dcb a (ptx dose: 3.5 mg/mm2 ; excipient: urea; manufacturer: medtronic), and dcb b (ptx dose: 2.0 mg/mm2 ; excipients: polysorbate and sorbitol; manufacturer: non-medtronic).Balloon selection was dependent on availability as dcb b was available beginning in 2012 and dcb a became available in 2015.Survival, amputation-free survival (afs), freedom from major amputation (ffamp), and freedom from target vessel revascularization (ff-tvr) were compared using kaplan-meier survival analysis.Of 1165 patients, 44.3% were treated with poba and 55.7% with dcb of which 58.4% with dcb a and 41.6% with dcb b.Baseline comorbidities and rutherford class were similar among the groups except poba patients had higher average creatinine and patients treated with dcb b less often had chronic limb-threatening ischemia.Average balloon length and number were similar among the groups.Treatment with dcb a demonstrated a significant advantage over poba in survival (64.2% vs 51.0%), afs (64.3% vs 46.0%), ff-amp (93.0% vs 85.6%), and ff-tvr (76.0% vs 72.5%).Dcb b was superior to poba only with regard to afs (56.9% vs 46.0%), but not survival (60.2% vs 51.0%), ffamp (88.5% vs 85.6%), or ff-tvr (72.5% vs 72.5%).Between the two dc bs, there were numeric, but not statistically significant, advantages for dcb a in survival (64.4% vs 60.2%), afs (64.3% vs 56.9%), ff-amp (93.0% vs 88.5%) and ff-tvr (76.0% vs 72.5%).The author concludes individual dcbs may not yield equivalent outcomes.Through 4 years of follow-up, dcb a showed a clear advantage in revascularization of the femoropopliteal segment over poba.Dcb b had a less clear advantage.Further studies are needed to determine the ideal excipients, ptx compositions, and ptx dose for dcbs.

• 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: 10336968
• MDR Text Key: 200835137
• Report Number: 9612164-2020-02768
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2020

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: 07/15/2020
• Initial Date FDA Received: 07/29/2020
• 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