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

Catalog Number RSINT25030JX

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

Patient Problems Occlusion (1984); Shock (2072); Thrombosis (2100)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Continued from event date month and year valid continued from implant date month and year valid bmj case reports "spontaneous closure of ventricular septal perforation following percutaneous coronary intervention for acute myocardial infarction" doi:10.1136/bcr-2017-221204.

Event Description

Index procedure was prompted by myocardial infarction.During the procedure, two resolute integrity drug eluting stents were implanted in the proximal and mid lad successfully.Post operatively, no murmur was audible on auscultation and no shunt flow was observed on transthoracic echocardiography and normal blood pressure was maintained.A day later the patient's vital parameters deteriorated to a state of shock with a systolic blood pressure of approximately 70mmhg.Auscultation revealed a systolic murmur with an apical thrill that was not detected at admission.Patient was treated with medication and acute heart failure subsequently improved.The deterioration of the vital parameters of the patient to a state of shock and akinesis along with the consequent decrease in blood in areas already suffering from low blood flow may have combined in a complex manner to promote thrombus formation, resulting in its spontaneous closure.

Manufacturer Narrative

Images provide show that transthoracic echocardiography on admission revealed decreased anteroseptal wall movement with a low left ventricular ejection of 35%.Coronary angiography revealed 90% stenosis at #6 (ostium) and occlusion at #7 , and percutaneous coronary intervention was performed.Two resolute integrity stents were placed, and the procedure was concluded with timl3 flow without complications.Transthoracic echocardiography showed a left-to-right shunt with a 2.7 mm diameter defect in the region of the apical septal akinesis, and a ventricular septal perforation was diagnosed.The disappearance of the cardiac murmur and the left-to-right shunt was confirmed on hospital day 3 the next day ventricular septal perforation was confirmed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information : the systolic murmur was not related to the implanted resolute stents the left-to-right shunt of approximately 2.7 mm that was noted in the region of the apical septal akinesis was not related to the implanted resolute stents the ventricular septal perforation was not related to the resolute stents a thrombus was confirmed in the ventricles.There was no issue with the implanted resolute and no thrombus was confirmed inside it.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the patient's current status is stable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 7099632
• MDR Text Key: 94256226
• Report Number: 9612164-2017-01845
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110013
• 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,Followup,Followup,Followup,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2018
• Device Catalogue Number: RSINT25030JX
• Device Lot Number: 0008163631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2018
• Date Device Manufactured: 08/05/2016
• 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): Other
• Patient Age: 84 YR
• Patient Weight: 50