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

Catalog Number 1070400-23

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problems Perforation (2001); Foreign Body In Patient (2687); Pericardial Effusion (3271)

Event Date 09/20/2019

Event Type  Death  

Manufacturer Narrative

Exemption number (b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a proximal left anterior descending artery.Post stent implant of the 4.0x23mm xience xpedition stent, there was resistance felt with the anatomy due to a high degree of calcinosis and the delivery catheter separated at the guide wire exit notch.An attempt was made to press the distal portion to the artery wall using an unspecified stent then a stent graft but was unsuccessful and it remains in the patient.A perforation occurred resulting in pericardial effusion and the patient died.Per the physician, the cause of death was a coronary artery perforation and pericardial effusion.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of perforation, pericardial effusion and death are listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as known patient effects of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effect(s) and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.D10- device available for eval.Updated from yes to no.

• 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: 9182545
• MDR Text Key: 162050774
• Report Number: 2024168-2019-12567
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Catalogue Number: 1070400-23
• Device Lot Number: 9030541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 85