MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT PACIFIC; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Device Problems Burst Container or Vessel (1074); Difficult or Delayed Positioning (1157); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

¿please note that this device (in.Pact pacific) is not marketed in the united states; however, it is similar to the united states marketed device (in.Pact admiral).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the inpact pacific drug eluting pta balloon catheter.Survey results from an interventional cardiologist in practice 18 years.Physician has been using medtronic¿s in.Pact pacific paclitaxel-eluting pta balloon catheter since 2016, using a total of 150 in the last year during percutaneous transluminal angioplasty (pta) procedures, in patients with obstructive disease of peripheral arteries.During use of medtronic¿s in.Pact pacific paclitaxel-eluting pta balloon catheter the following complications were reported associated with the use of the device (not related to the paclitaxel drug coating): abrupt vessel closure/thrombosis (acute total occlusion/reocclusion that may require surgical intervention) due to detachment of plaque (reported in 4 patients), access site pain, hematoma, haemorrhage, and/or local infection (bleeding may require transfusion) reported as local hematoma (reported in 30 patients), allergic reaction to contrast medium, antiplatelet therapy, or catheter system components reported as an unknown allergy to the contrast medium (reported in 3 patients), aneurysm, pseudoaneurysm, or arteriovenous (av) fistula reported as a training post-op aneurysm (reported in 5 patients), balloon rupture during inflation (reported in 3 patients), failure of the balloon to perform as intended (inflation/deflation/retrieval) reported as unable to inflate (reported in 2 patients), failure to deliver the balloon as intended (may release drug into unintended arterial segment) due to vessel lumen being to small (reported in 3 patients), hypotension/hypertension due to intraoperative circulatory dysregulation (reported in 5 patients), local or distal thromboembolic episodes reported as detachment of a plaque (reported in 5 patients), pain and tenderness at puncture sites reported as postop.Pain vas 3-4 (reported in 30 patients), pyrogenic reaction reported as postop.Temperature (reported in 15 patients), and restenosis of the dilated artery due to the stenosis not being completely dilated (reported in 10 patients) during use of medtronic¿s in.Pact pacific paclitaxel-eluting pta balloon catheter there were no complications reported associated with the paclitaxel drug coating.Of the above ae¿s reported for medtronic¿s in.Pact pacific paclitaxel-eluting pta balloon catheter; some of these are listed as having been previously reported to medtronic.Due to limited information these are included in reporting.

• Brand Name: IN.PACT PACIFIC
• 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: 8627650
• MDR Text Key: 145635941
• Report Number: 9612164-2019-01861
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/21/2019
• 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