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 Angina (1710); Cardiac Arrest (1762); Myocardial Infarction (1969); Thrombosis (2100); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 05/10/2017

Event Type  Injury  

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.The reported patient effects of myocardial infarction, thrombosis, ventricular fibrillation and ventricular tachycardia, 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.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 and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that on (b)(6) 2014, the patient underwent a coronary procedure with implantation of a 3.0 x 28 mm absorb bioresorbable vascular scaffold (bvs) in the mid left anterior descending (lad) artery.On (b)(6) 2017, the patient experienced chest pain and was transported to the hospital via ambulance.During the ride to the hospital, the patient experienced ventricular fibrillation cardiac arrest and was treated with cardiopulmonary resuscitation (cpr) and defibrillation.The patient returned to spontaneous circulation.The patient went into cardiac arrest again while in the emergency room and was treated with cpr and defibrillation.The patient went into pulseless electrical activity (pea) and required additional cpr, as well as adrenaline.The patient returned to spontaneous circulation, but was in ventricular tachycardia.Three synchronized shocks and amiodarone were administered and the patient went into normal sinus rhythm with st elevation myocardial infarction.The patient was transferred to another facility for percutaneous coronary intervention.Coronary angiography noted that the implanted scaffold was occluded with thrombus.A stent was implanted at the target lesion in the lad.The patient condition resolved on (b)(6) 2017 and medications were changed from aspirin and clopidogrel to aspirin and ticagrelor.No additional information was provided.

• 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: 7268408
• MDR Text Key: 99987423
• Report Number: 2024168-2018-01074
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2015
• Device Catalogue Number: 1012463-28
• Device Lot Number: 4070761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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; Disability
• Patient Age: 63 YR
• Patient Weight: 98