MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Gastritis (1874); Myocardial Infarction (1969); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Journal title: utilization of ticagrelor as a sole anti-platelet agent in a patient with high risk of bleeding and an anomalous origin of left anterior descending coronary artery from right coronary artery.If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute integrity rx coronary drug-eluting stent was implanted to treat a lesion exhibiting 90% stenosis located in the mid right coronary artery (rca).Aspirin, clopidogrel, atorvastatin, metoprolol and esomeprazole were prescribed to be taken twice daily following the procedure.It was reported that two weeks after the procedure the patient came back presenting with profound fatigue, dyspnea, tarry stool, pallor and hemoglobin of 8g.The patient was stabilised with two units of blood and a upper gastrointestinal (ugi) endoscopy was performed which revealed erosive gastritis.Following this, the patient presented with three further episodes of ugi bleeding over 4 months.All four episodes of bleeding were managed with intravenous proton pump inhibitor.Aspirin was discontinued permanently after the fourth episode.Nine months after initially presenting with typical angina, the patient developed chest pain at rest with t-wave inversions involving the inferior leads plus elevated troponin congruent with acute myocardial infarction was also observed.Another pci was performed using the same type of stent.Ticagrelor was then prescribed as the only antiplatelet agent.The patient was noted to be comfortable and without bleeding 2 months post implantation of the new resolute integrity stent.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9562368
• MDR Text Key: 182396081
• Report Number: 9612164-2020-00124
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: ET
• PMA/PMN Number: P110013
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR