MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER UNK GUIDE CATHETER; CATHETER, PERCUTANEOUS

Lot Number UNKNOWN

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

Patient Problems Chest Pain (1776); Hematoma (1884); Ventricular Fibrillation (2130); Aortic Dissection (2491); Vascular System (Circulation), Impaired (2572)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

Literature reference: doi: 10.5543/tkda.2017.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

From the literature article: electrocardiography indicated normal sinus rhythm without any abnormality.A treadmill exercise test yielded an abnormal result with ischemic st changes.Coronary angiography showed no significant lesion in the left coronary arteries, but a 70% lesion was detected in the proximal rca.The decision was made to perform a pci to the rca lesion.The rca was engaged with a jr4-6f launcher guide catheter.After the first contrast injection, an rca osteal dissection extending to the ascending aorta was apparent.The patient experienced a sudden onset of chest pain with hemodynamic instability.The patient developed ventricular fibrillation and was converted to sinus rhythm with defibrillation.The dissection was passed with a hi torque balance middleweight universal non-medtronic guidewire and a bare-metal stent (3.5x12 mm, integrity bms) was implanted from the proximal segment to the ostium of the rca.The patient stabilized hemodynamically.A follow-up angiogram revealed no contrast leakage to the false lumen of the rca.A second bare-metal stent (3.0x15 mm, integrity bms) was also implanted at the mid segment of the rca, over-lapping with the proximal stent in order to cover whole dissection line.Anticoagulation therapy was not reversed due to achieving hemodynamic stability and a complete seal of the origin of the dissection with the stent.Emergent computed tomography (ct) aortography performed just after the procedure revealed an intramural hematoma formation with contrast retention in the proximal segment of the ascending aorta.Antiplatelet medications were continued in the intensive care unit.The patient developed no further adverse event during the remainder of the hospital stay and follow-up ct scans 24 hours and 72 hours after the procedure demonstrated a complete resolution of the false lumen.The patient was discharged uneventfully after a week.

• Brand Name: LAUNCHER UNK GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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 ; 091708734
• MDR Report Key: 7380715
• MDR Text Key: 103778852
• Report Number: 1220452-2018-00032
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K021256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2018
• 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: 64 YR