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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK RX XPEDITION
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Perforation of Vessels (2135); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Pericardial Effusion (3271)
Event Date 07/08/2021
Event Type  Death  
Manufacturer Narrative
Estimated date of death. Estimated date of event. Estimated date of implant. The device is retained by hospital and not returning for analysis. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a complete occlusion of the mid-left anterior descending artery (lad) via a percutaneous coronary intervention with a 3x28mm xience xpedition stent. Post stent implantation, there was no evidence of proximal lad dissection and there was good flow distally. Ten days later, the patient experienced cardiogenic shock and temponading pericardial effusion. 250 ml of clotted blood was evacuated via a subxiphoid (incision) pericardial window. The patient remained in hospital for 2 more weeks for recovery and during this time developed staphylococcus aureus bacteraemia secondary to hospital-acquired pneumonia, which was treated with intravenous antibiotics and a deep vein thrombosis occurred despite prophylactic enoxaparin. Patients respiratory status continued to deteriorate, and a computed-tomography scan of the chest revealed bilateral pulmonary emboli, a 5. 3-cm posterior loculated pericardial effusion, and a 3. 1-cm proximal lad pseudoaneurysm. There was no distal flow in the lad. Due to the large size of the pseudoaneurysm, the patient was sent to surgery (midline sternotomy and full heparinisation). At the time of surgery, the patient had signs of sepsis with high fevers and elevated white blood cell counts. The pericardium was noted to be grossly inflamed. Cardiopulmonary bypass (cpb) was established. Additionally, it was also noted that the pseudoaneurysm had ruptured. The lad stent had detached at its proximal end but was still attached at its distal end, therefore the stent implant was removed via coronary artery bypass grafting. The posterior pericardial collection was then drained, with large amounts of clotted fibrinous material removed. Following the pseudoaneurysm repair and pericardial collection drainage, there was large ongoing bleeding throughout the heart and chest despite many attempts at hemostasis and provision of blood products. Hemodynamic instability continued throughout the case despite provision of high doses of multiple inotropic agents. The patient was unable to be weaned off cardiopulmonary bypass and further attempts at resuscitation were ceased and ultimately expired.
 
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Brand NameXIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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 Key12541021
MDR Text Key273627993
Report Number2024168-2021-08675
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeNZ
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RX XPEDITION
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 Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/28/2021 Patient Sequence Number: 1
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