MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1128350-23

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Vasoconstriction (2126); Cardiogenic Shock (2262)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: bmw universal ii , whisper extra support, whisper ms, medtronic nc.Guide catheter: medtronic launcher ebu 3.75 6f.Stent: 2.75x33mm xience proa.The customer reported the device remains in the anatomy.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional 2.75x33mm xience proa device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2019, the patient was admitted to the hospital due to a heart attack.St- elevation myocardial infarction was noted in the circumflex (cx) lesion and percutaneous coronary intervention (pci) was performed.A 3.50x23mm xience proa stent was implanted in the cx without complications.Further diagnostics were planned for the left anterior descending (lad) to diagonal (dx) lesion and thrombus noted in the first obtuse marginal (om1).On (b)(6) 2019, after introducing the dragonfly catheter and the optical coherence tomography (oct) pullback recording, it was noted that the cx and lad were totally closed due to massive spasm and secondary thrombus.Pci at the lad and dx were performed successfully with a 2.75x33mm xience proa stent implanted in the lad.The patient experienced symptoms of cardiogenic shock which then led to a cardiac arrest.Resuscitation was initiated with an extracorporeal membrane oxygenation.Once the patient re-stabilized, oct was performed with another dragon fly and noted thrombus in the lad stent region.Residual thrombus in the cx and lad was treated with a 2.75x20 non-abbott balloon.After administration of nitroglycerin, the vessels were well visible.On (b)(6) 2019, the patient was noted as stable and remains in the intensive care unit.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned to abbott vascular for analysis.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 cardiac arrest, hypotension, thrombosis, and shock are listed in the xience proa, ce everolimus eluting coronary stent system, instructions for use, as known patient effects.There was no reported device malfunction.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 of the device.

Event Description

Subsequent to the initially filed mdr report, the account confirmed that after the massive spams in both vessels, the patient experienced hypotension.The spasms in the vessel were noted before starting the oct procedure.Additionally, the patient was compliant with dual antiplatelet drug therapy after the procedure.No additional information was provided.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8374542
• MDR Text Key: 137281031
• Report Number: 2024168-2019-01502
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2021
• Device Catalogue Number: 1128350-23
• Device Lot Number: 8100461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 85