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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE XPEDITION DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1078300-48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); Test Result (2695)
Event Date 11/24/2019
Event Type  Death  
Manufacturer Narrative
The stent remains in patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The other additional xience sierra and xience xpedition stents referenced are being filed under separate medwatch report numbers.
 
Event Description
It was reported on feb 15, 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.
 
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Brand NameXIENCE XPEDITION
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9812148
MDR Text Key182752349
Report Number2024168-2020-02209
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received03/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1078300-48
Device Lot Number9081341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/10/2020 Patient Sequence Number: 1
Treatment
(2) 2.25X38MM XIENCE SIERRA; (2) 2.5X48 XIENCE XPEDITION; 3.25X23MM XIENCE SIERRA
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