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

Model Number 1550300-23

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Obstruction/Occlusion (2422); Prolapse (2475); Thrombosis/Thrombus (4440)

Event Date 05/27/2021

Event Type  Death  

Manufacturer Narrative

The stent remains in the patient.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 performed to treat a in-stent restenosis in the left anterior descending (lad).A 3.0 x 23 mm xience sierra stent delivery system (sds) was advanced to the target lesion and the stent was implanted.However, it was noted that plaque shift had occurred which caused an obstruction to the septal and diagonal branches.The physician was able to use a guide wire to open up the branches.The procedure was completed.When the patient was taken off the table, the patient coded (cardiopulmonary arrest).The patient was put back on the table and stent thrombosis was noted.Aspiration was performed to treat the thrombus.A 4.0 x 23 mm xience sierra stent was implanted in lad to the left main artery.The patient was taken to the recovery room and died shortly after.The patient had a history of not being compliant with the dual antiplatelet drug therapy (dapt).No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported wall apposition.The reported patient effects of thrombosis, occlusion, prolapse and death are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.Medical affairs reviewed the reported information.The reviewer concluded that based on the limited information provided, it can be stated that the cause of death was due to acute thrombosis secondary to procedural complication and not directly related to both xience sierra stents.The stents were not fully expanded and not well apposed to the vessel wall plus the reported non-compliance to dapt all could have contributed to the development of thrombus.Xience sierra stents did not cause or contribute to this patient¿s death.The additional device referenced in b5 is filed under a separate medwatch report number - 2024168-2021-06172-00na.

Event Description

It was reported that the procedure was performed to treat an in-stent restenosis in the left anterior descending (lad).A 3.0 x 23 mm xience sierra stent delivery system (sds) was advanced to the target lesion and the stent was implanted.However, it was noted that plaque shift had occurred which caused an obstruction to the septal and diagonal branches.The physician was able to use a guide wire to open up the branches.The procedure was completed.When the patient was taken off the table, the patient coded (cardiopulmonary arrest).Cardiopulmonary resuscitation (cpr) defibrillator and intra-aortic balloon pump therapy were used the patient was put back on the table and stent thrombosis was noted.Aspiration was performed to treat the thrombus.Additionally, a 4.0 x 23 mm xience sierra stent was implanted in lad to the left main artery.The patient was taken to the recovery room and died shortly after on (b)(6) 2021 due to acute thrombosis.In the physician's opinion, the xience sierra stents did not cause or contribute to the death, but the stents were suspected to be not fully expanded.Additionally, the patient had a history of being not compliant with the dual antiplatelet drug therapy (dapt).No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 12017318
• MDR Text Key: 256736167
• Report Number: 2024168-2021-05082
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1550300-23
• Device Catalogue Number: 1550300-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 64