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.

Manufacturer Narrative

D4: the udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product were not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of death, pseudoaneurysm, occlusion, hypotension and perforation are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A cine was received and reviewed by an abbott vascular clinical specialist and noted the following: this case report of a ruptured giant pseudoaneurysm, most likely due to sepsis/infection as mentioned in the article that the patient was displaying signs of sepsis preoperatively (high fevers, elevated white blood cell counts, and positive blood cultures for s.Aureus).Furthermore, direct microbiological analysis of the intraoperative pseudoaneurysm and stent tissue revealed growth of bacillus species; these organisms have previously been shown to cause large-vessel arterial mycotic aneurysms.The investigation was unable to determine a conclusive cause for the reported wall apposition; however, factors that may contribute to wall apposition include, but are not limited to; incorrect device size for lesion, patient anatomical morphology, and patient disease state.The reported patient effects and subsequent treatment appears to be related to operational context of the procedure and/or the patients overall condition.A medical review was performed and found that not a lot of procedural or medical history was provided in the journal article.The patients¿ possible immunocompromised state, his subsequent infection and septic state, the multiple complications during the patient¿s hospital stay, and the stemi condition all contributed to this patient¿s death.The xience xpedition did not cause or contribute to the patient¿s death or the development of the giant pseudoaneurysm.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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
• 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
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• 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: Health Professional
• Device Catalogue Number: UNK RX XPEDITION
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR