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

Catalog Number 1011711-28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Ventricular Tachycardia (2132); Diaphoresis (2452)

Event Date 12/02/2019

Event Type  Death  

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The stent remains in patient.The device will not be returned for evaluation.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 on (b)(6) 2019 to treat a lesion in the 100% stenosed left circumflex coronary artery.A non-abbott thrombus extraction catheter was used for thrombus aspiration.An unspecified 2.5x12mm balloon dilatation catheter (bdc) was used for pre-dilatation.A 4x28mm xience prime stent was implanted, and an unspecified 4mm bdc was used for post-dilatation.On (b)(6) 2019, the patient experienced ventricular tachycardia, sweating, and expired.On the day of death, the patient had stent thrombosis and is being considered the primary cause of death.There was no reported clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: although there was no residual stenosis after the initial procedure, the patient had stent thrombosis on the date of death, and this is being considered the primary cause of death.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of ventricular tachycardia, thrombosis and death are listed in the xience prime everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A medical review was provided by an abbott vascular clinical specialist.The reviewer concluded the following: a 55-year-old female presented with ami and came in for percutaneous coronary intervention on a 100% occluded left circumflex.A 7f thrombuster catheter was used for thrombus aspiration.A 4x28mm xience prime stent was implanted after pre-dilatation with 2.5x12 mm unknown balloon and post dilated with 4.0 mm unknown balloon.Patient had ventricular tachycardia 1-day post-procedure and expired.The cause of death is most likely secondary to subacute stent thrombosis.There¿s no information provided in relation to vessel sizing.Dual anti-platelet therapy (dapt) or any residual thrombus after the aspiration and stent placement could have contributed to the occurrence of stent thrombosis.One of the most important predictors of early and late stent thrombosis is absence of platelet p2y12 receptor blocker therapy (dapt) at the time of the event.The intracoronary and systemic prothrombotic environment accompanying an acute coronary syndrome (acs) shows a possible increase in the risk of stent thrombosis compared to stable angina as confirmed in analyses of the acuity and triton-timi 38 trial.New information provided by the site.Dapt treatment initiated after procedure.No angiographic residual thrombus noted per site.Main cause of death is cardiac related to subacute stent thrombosis and relationship to xience prime cannot be fully ruled out.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3: date of event changed from (b)(6) 2019 to (b)(6) 2019.

• Brand Name: XIENCE PRIME 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: 9495018
• MDR Text Key: 171994794
• Report Number: 2024168-2019-14740
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: 1011711-28
• Device Lot Number: 9020441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR