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

Catalog Number 1011707-38

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

Patient Problems Cardiac Arrest (1762); Ventricular Tachycardia (2132)

Event Date 01/10/2020

Event Type  Death  

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 effect(s) of ventricular tachycardia and death are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use, as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the 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.

Event Description

It was reported that the procedure was performed on (b)(6) 2020 to treat a de novo lesion in the moderately calcified, mildly tortuous proximal left anterior descending (lad) coronary artery and a de novo lesion in mildly calcified, mildly tortuous proximal left circumflex (lcx) coronary artery.The patient was presented with myocardial infarction.A 2.5x38mm xience prime stent delivery system (sds) was advanced, and the stent was implanted in the proximal lad.The patient experienced ventricular tachycardia (vt) and a defibrillator was used.A 2.75x12mm xience prime sds was advanced, and the stent was implanted in the lcx.A 2.5x8mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation.The patient was stabilized and then sent to icu.On (b)(6) 2020, the patient experienced vt, so cpr was given as treatment.The patient then experienced cardiac arrest, and the patient expired.In the physicians opinion, the 2.5x38mm xience prime stent did not cause or contribute to the death.There were no issues with the devices.No additional information was provided.

Event Description

Subsequent to filing the initial report, the following additional information was received: the patient presented with an acute myocardial infarction.The patient was on statins and betablockers angiotensin-converting enzyme (ace) inhibitors.The angiography indicated medina class 1 0 1 classification.The target lesion was located in the distal left main to left anterior descending artery.The stenting was performed at 1:50 pm.After the intervention, the patient was placed on anticoagulants clopidogrel and aspirin.The patient died at 3:20 am, and no autopsy was performed following the patient's death.No additional information was provided.

Manufacturer Narrative

Nah6: investigation conclusions code 4315 added.

• Brand Name: XIENCE PRIME LL 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: 9647486
• MDR Text Key: 176981618
• Report Number: 2024168-2020-01024
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Catalogue Number: 1011707-38
• Device Lot Number: 9040341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.75X12MM XIENCE PRIME.; 2.75X12MM XIENCE PRIME
• Patient Outcome(s): Death