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

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.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG 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 Key: 12541021
• MDR Text Key: 273627993
• Report Number: 2024168-2021-08675
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• 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 Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK 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 Received: 10/11/2021
• 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