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

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombus (2101); Cardiac Tamponade (2226)

Event Date 11/01/2012

Event Type  Death  

Event Description

This literature review reported a case of intravascular myocardial emboli associated with acute myocardial infarction following cardiac catheterization.The physician was attempting to treat a patient with 90% stenosis of the circumflex.The maximal percent of coronary narrowing by atherosclerosis was left anterior descending, 70%, right coronary, 60%; circumflex, 80%.An unknown brand bare metal stent was placed in the proximal circumflex.A sprinter legend balloon, launcher guide catheter, non-medtronic guidewire and a non-medtronic ivus imaging catheter were used during the procedure.The procedure was complicated by thrombus formation in the circumflex which was treated with thrombectomy and mechanical aspiration using a non-medtronic aspiration catheter.The patient was discharged in stable condition and was readmitted one month after the procedure for a syncopal episode.Shortly after admission, the patient suffered a cardia c arrest and expired.Autopsy revealed hemopericardium with rupture of the left ventricle through a pseudoaneurysm present within an area of prior infarction (measuring 6.5×6.0 cm) of the left ventricular free wall, in the territory of the circumflex artery.A bare metal stent was in place in the proximal circumflex and was patent.Microscopically, the myocardium of the left ventricular free wall adjacent to the site of rupture showed acute infarction characterized by early coagulative necrosis.The acute infarct was similarly present within the distribution of the circumflex.Numerous small and medium sized vessels within the left ventricle showed partial occlusion by basophilic filamentous to amorphous granular material with an inflammatory giant cell response.The foreign material was nonpolarizable and nonrefractile and was not identified in other areas of the heart.The journal article hypothesized that the patient's rapid clinical decompensation and the finding of early coagulative necrosis at the site of rupture suggested that cardiac rupture occurred shortly preceding the patient's death.The journal article further hypothesized that while the patient's ultimate cause of death was cardiac tamponade, hydrophilic polymer emboli were most frequent in the area of acute infarction, suggesting that the emboli may have resulted in ischemia leading to the patient's death.

Manufacturer Narrative

Evaluation codes, results: inherent risk of procedure (thrombus, mi, death) other (root cause undetermined) no results available since no evaluation was performed (no device received for evaluation) evaluation codes, conclusions: known inherent risk of procedure (thrombus, mi and death) other (root cause undetermined) unable to confirm complaint (no device received for evaluation) device not returned (b)(4).The information could not be matched with other information known to medtronic.Cardiovascular pathology 23 (2014) 175 ¿ 177.Http://dx.Doi.Org/10.1016/j.Carpath.2014.01.009 "myocardial hydrophilic polymer emboli following cardiac catheterization: a case report and literature review¿.

• Brand Name: LAUNCHER GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 4719490
• MDR Text Key: 5751590
• Report Number: 1220452-2015-00017
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• 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
• Date Manufacturer Received: 03/23/2015
• 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): Death; Required Intervention
• Patient Age: 00065 YR