MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1078250-48

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

Patient Problems Myocardial Infarction (1969); Test Result (2695)

Event Date 11/24/2019

Event Type  Injury  

Manufacturer Narrative

The other additional xience sierra and xience xpedition stents referenced are being filed under separate medwatch report numbers.The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported on (b)(6) 2020 via chiba vascular intervention conference, in a presentation titled ¿stent thrombosis which occurred after an emergent pci for severe nstemi presenting culprit shock,¿ that the following occurred: a patient was hospitalized on (b)(6) 2019, as they presented with non-st elevation myocardial infarction, hypertension, cardiogenic shock and diabetes.Additionally, hepatopathy and nephropathy were also noted.Angiography was performed which showed 99% stenosis at the mid-distal right coronary artery (rca), 90% stenosis at the proximal-distal left anterior descending artery (lad) and 100% stenosis at the distal circumflex (cx) with 20% ejection fraction (ef).The rca lesion was treated first and predilatation was performed.A 2.25x38mm xience sierra stent was deployed at 8 atmospheres (atm) to 16 atm from the posterial lateral to the distal rca.Then the second stent implanted at 11 atmospheres was a 2.5x48mm xience xpedition at the mid rca.Finally a third stent (3.25x23mm xience sierra) was implanted at 12 atm at the proximal rca.Post-dilatation was performed and intravascular ultrasound was conducted.Although bad-flow was noted, the lesion was opened and the procedure completed.Also, medication was provided for treatment as well.The lad lesion was planned next but since 170cc contrast was used for rca and due to nephropathy, the procedure was finished without treating the lad.On day 3 (b)(6) 2019), the intra-aortic balloon pump (iabp) was removed.On day 4 ((b)(6) 2019), the patient was discharged from the intensive care unit.The physician determined the outcome was better than expected.However, on day 20 ((b)(6) 2019), the patient was re-hospitalized.Angiography by electrocardiogram was performed and noted thrombus from the proximal-distal rca.Therefore, (3) additional xience stents (2.25x38mm xience sierra, 2.5x48mm xience xpedition, 3.0x48mm xience xpedition) were implanted from distal-proximal rca.Afterwards, a blood test was conducted and it was determined that the patient was positive for heparin-induced thrombocytopenia (hit) antibody.Additionally, the iabp was reinserted today again.On day 29, the patient was released from the iabp, but the condition was still bad.Therefore the iabp was re-inserted again on day 30 ((b)(6) 2019).As ef value did not improve, intervention for the lad lesion was performed.A xience xpedition 48mm was attempted to be advanced but failed to cross due to the anatomy.The device was replaced with a shorter sized non-abbott stent.The patient condition did not improve.Throughout all stent implantations, the patient was compliant with dual antiplatelet drug therapy.On day 47 ((b)(6) 2019), the patient died due to acute myocardial infarction.An autopsy was not performed.Per the physician, he did not think that all the xience stents caused or contributed to the patients death, but cannot confirm which were responsible.Afterwards, the physician determined that the cause of the subacute thrombosis was not due to the xience stents, but due to low cardiac function, nephropathy, low ef value, the flow did not recover as it was after the stents were implanted, and hit antibody-positive.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of myocardial infarction is listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9812084
• MDR Text Key: 184265546
• Report Number: 2024168-2020-02207
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Catalogue Number: 1078250-48
• Device Lot Number: 9080941
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2) 2.25X38MM XIENCE SIERRA; 2.5X48 XIENCE XPEDITION 48; 3.0X48 XIENCE XPEDITION; 3.25X23MM XIENCE SIERRA
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 67 YR