MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER

Model Number UNK-DAN-LAUNCHER

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

Patient Problems Intimal Dissection (1333); Arrhythmia (1721); Perforation (2001)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The aim of this study was to evaluate the safety and efficacy of bpa treatment in inoperable chronic thromboembolic pulmonary hypertension (cteph) and chronic thromboembolic disease (cted) patients and present the first results of the two specialised cteph centres in the (b)(6) all patients accepted for balloon pulmonary angioplasty (bpa) in the (b)(6) hospital in (b)(6) between january 2016 and october 2018, and in the (b)(6) between june 2015 and february 2019, were included in this study.A medtronic guiding catheter was used during some procedures in the (b)(6) facility.Bpa procedures were performed using femoral access with a non-medtronic 6f destination sheath and a 6f medtronic or non-medtronic guiding catheter.A 0.014-inch guide wire was directed into the affected pulmonary artery branches, which were visualised with iodixanol.Dilatation was performed with semicompliant non-medtronic balloons.The procedure ended if a maximum of ten segments in one lung were treated or more than 200ml contrast was used.Time to the next bpa procedure varied between four to six weeks.Patients were monitored for potential complications at the coronary care unit or pulmonary ward.In total, 172 bpa sessions were performed.The total hospital stay was between 1.5 and 2.1 days per bpa session.38 patients had completed their treatment and six-month follow-up before the end of the study period.Patients excluded from follow-up included 4 patients who died before the six-month follow-up evaluation.The four patients in the (b)(6) that died before their six-month followup, died due to metastatic cancer (diagnosed after final bpa), hip fracture and right ventricular failure.Complications reported included mild haemoptysis, temporary conduction or rhythm disturbances, pulmonary vascular dissection and pulmonary vascular perforation.Three episodes of temporary conduction and rhythm disturbances were observed after bpa, which resolved spontaneously; so clinical importance was low.Although severe pulmonary artery injury was not observed in the patients with haemoptysis during angiographic evaluation, except for one pulmonary vascular perforation, it is noted that it is likely that the haemoptysis was caused by small pulmonary vascular injuries.It is mentioned that it was striking that one patient experienced haemoptysis during three different bpa procedures, but this patient had severe impaired pulmonary haemodynamics, which may explain the increased risk and occurrence of complications.The usual treatments with balloon occlusion of the vessel, protamine infusion and continuous positive airway pressure were also effective in these patients.

• Brand Name: LAUNCHER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10194582
• MDR Text Key: 196593112
• Report Number: 1220452-2020-00050
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: UNK-DAN-LAUNCHER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR