MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012463-28

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Stenosis (2263); Coma (2417)

Event Date 10/18/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Ecs attempts resulted in fibrillation.Multiple rca recanalization attempts were not successful as well.It was decided to perform cabg.Six episodes of heart massage in cath lab.During surgery, the patient experienced fibrillation, heart and lung resusitation were performed with short-term results.Fibrillation episodes resulted in asystolia.Heart and lung resusitation was performed with no effect and the patient died.According to the information from the intensive care specialists, scaffold thrombosis was revealed on the section.The thrombosis was not treated because there was no ability to give the patient any pill and no time to change the therapy scheme.The reported cause of death was scaffold thrombosis.The patient was confirmed to have been compliant in following the dual antiplatelet drug therapy (dapt) after the procedure.Besides the scaffold thrombosis they found an acute mi of the posterior wall of the left ventricle (lv) and an acute ischemic dystrophy of the myocardium.Also they found post-infarction multifocal (small focuses) cardiosclerosis on the anterior wall of lv.This may tell us that some time ago the patient had an episode of mi.But there was no indications in anamnesis if they had an mi sometime.All these focuses were very small, so, probably, the episode of mi has never been diagnosed and most probably had been recognized as an angina attack, falsely.Also they found nephrosclerosis on both-sides and chronic pyelonephritis (remission stage) which were not related to the absorb.Renal insufficiency or failure were excluded.No additional information was provided.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that the patient presented with atherosclerosis, ischemic heart disease and exertional angina, grade ii-iii.On (b)(6) 2016 angiography was performed and 80% stenosis of the distal right coronary artery (rca) was revealed.Predilatation was performed with a 3.0x20 mm nc non-abbott balloon using 14 atmospheres (atm) with the residual stenosis reduced to less than 40%.Then a 3.0x28 mm absorb scaffold was implanted with 12 atm.Post-dilatation was performed with a 3.25x15mm non-abbott balloon using 18 atm with the final angiographic residual stenosis less than 10%.A control angio noted the lumen was restored completely with timi iii blood flow, no spasm or peripheral section.The patient was prescribed coplavix (1 pill per day).No intravascular ultrasound or optical coherence tomography was performed so the absorb scaffold could not be confirmed to be fully apposed to the vessel wall.On (b)(6) 2016 a carotid procedure was performed.After the operation, while in the intensive care unit, negative changes of hemodynamics in posterior wall were detected, on echocardiography (ecg) - no kinetics of right ventricle.The patient was transported into the cath lab for an urgent angiography.On angiography, no visualisation of rca (starting from the ostium) and thrombosis of the scaffold was detected.The patient status was critical, unstable hemodynamics, hypotension.Aortic pressure = 80 mmhg, ventricle fibrillation and tachycardia episodes, which changed with bradycardia episodes (45-50 bpm).

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A cine was received and reviewed by an abbott vascular physician.The reviewer stated: difficult review due to limited quality of videos and inability to see what was done.Cannot see an absorb scaffold definitely placed as there are no pictures of the deployment and the final angiogram video does not show any scaffold markers.Unusual case here where the incident report does not seem consistent with the pictures, but the pictures are poor quality which may be part of the problem in identifying whether a scaffold was even placed in this patient.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of cardiac arrest, death, hypotension, thrombosis and ventricular fibrillation, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• 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: 6159562
• MDR Text Key: 62073999
• Report Number: 2024168-2016-08768
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2017
• Device Catalogue Number: 1012463-28
• Device Lot Number: 5101561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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): Death
• Patient Age: 75 YR
• Patient Weight: 61