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

Model Number RSINT40022X

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

Patient Problems Myocardial Infarction (1969); Occlusion (1984); Shock (2072); Thrombus (2101)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The aim of this journal article is to demonstrate the use of a stent graft as an effective bailout method for complete sealing of plaque protrusion in uncontrollable ipst (intraprocedural stent thrombosis).This article details the case of a patient who developed uncontrollable intraprocedural stent thrombosis (ipst) during an emergent percutaneous coronary intervention for acute myocardial infarction that was mitigated only by covering the culprit lesion with a stent graft.The patient presented with complaints of chest pain.An electrocardiogram (ecg) revealed complete atrioventricular block (cavb), st segment elevation in leads ii and iii, and avf induction.The patient was subsequently diagnosed as having acute inferior wall myocardial infarction.Antiplatelet drugs, comprising 100 mg of aspirin and 300 mg of clopidogrel, were administered as the initial loading dose.Coronary angiography revealed total occlusion of the proximal site of the right coronary artery (rca) with thrombus formation.A severe stenotic lesion was also observed in the left anterior descending artery.Pci for rca was subsequently performed using a non-medtronic 7-fr guiding catheter, a non-medtronic microcatheter and non-medtronic guide wire which were successfully advanced distally, beyond the culprit lesion.Thereafter, a large amount of thrombus was aspirated using a non-medtronic thrombus aspiration catheter and reperfusion of the rca w as achieved.Intravascular ultrasonography (ivus) examination revealed a large amount of ruptured soft plaque and thrombus in the culprit lesion.A non-medtronic embolic protection device was advanced to the distal site of the rca in order to prevent distal embolization.Direct stenting was then performed using a resolute integrity (4.0 × 22 mm) rx drug-eluting stent.It was reported that intrastent thrombus and plaque protrusion at the proximal site of the implanted stent occurred with an increase in the intrastent thrombus being detected 20 mins later by ivus.An intra-aortic balloon pump was then used to improve coronary flow.Obvious stent malapposition and dissection of the stent edge were not detected.10,000 u of heparin were administered during the procedure, and the activated clotting time (act) was 224 s at the end of the procedure.As a result of angiographic findings not worsening, the patient was admitted to the coronary care unit.However, 30 min after the initial pci, the patient complained of chest pain again.A repeat ecg revealed st segment elevation in leads ii and iii, avf induction, and cavb.The patient subsequently went into a state of shock.Subsequent coronary angiography showed intrastent occlusion at the proximal site of the rca.A second pci was performed using a 7-fr non-medtronic guiding catheter and the anticoagulant being used was switched from heparin to argatroban.20 mg of prasugrel was simultaneously added to enhance the antiplatelet effect.Thrombus was was aspirated using a non-medtronic thrombus aspiration catheter and reperfusion of the rca was achieved.Despite this, there was rapid progression of the new thrombus, and in about 20 min, the rca lesion was sub-occluded.Although thrombus aspiration was repeated, the patient's condition did not improve.Consequently, a long inflation using a non-medtronic perfusion balloon was attempted to maintain the coronary flow.The stenosis with thrombus reduced after 30 minutes of dilation with the non-medtronic perfusion balloon.20 minutes following deflation of the balloon, the thrombus increased again, forming a coronary sub-occlusion at the culprit site.It was noted that the above-mentioned procedures were performed repeatedly, however, the thrombus continued to increase and recur in the stent.40 mg of argatroban was intravenously administered during pci, and an act of 348 s was achieved amidst the procedure.It was observed that the new thrombus appeared continuously from a specific point inside the stent that matched the intrastent plaque protrusion detected by ivus.From this, it is postulated that the intrastent plaque protrusion might have caused uncontrolled thro mbogenesis in the patient.A non-medtronic stent graft was implanted into the culprit lesion and completely sealed the intrastent plaque protrusion.The procedure was terminated following no appearance of a new thrombus even after 30 min, while maintaining the timi 3 flow.A new thrombus was not detected by coronary angiography two days after the procedure.The anticoagulant drug was switched from argatroban to dabigatran on day 5 of hospitalization.It is noted that the patient was deemed to be an extensive metabolizer based on the test for cyp2c19 gene polymorphism.A skin patch test performed after pci in the present patient tested negative, ruling out an allergy to the metal components of the stent.On day 27 of hospitalization, angiography and optical coherence tomography for the rca was performed and no evidence of stenosis was found.The thrombus in the rca had disappeared completely.It is noted that factors related to the procedures, including dissection of stent edge, remaining lesion stenosis, incomplete stent coverage, incomplete apposition, and incomplete expansion,5,7 can cause stent thrombosis.However, it is stated that in this patient, these procedural factors were not the principal causes of stent thrombosis, given that no dissection of stent edge or stent malapposition was found in the first pci session for rca.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10172688
• MDR Text Key: 198711585
• Report Number: 9612164-2020-02259
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RSINT40022X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/19/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR