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

Catalog Number 1012464-18

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

Patient Problems Cardiac Arrest (1762); Death (1802); Thrombosis (2100); Respiratory Failure (2484)

Event Date 04/03/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that on (b)(6) 2015, the patient was admitted with anterior st elevation myocardial infarction.A 3.5 x 18 mm absorb bioresorbable vascular scaffold (bvs) was implanted in the proximal left anterior descending (lad) artery to treat 100% stenosis and reducing stenosis to 0%.Moderate to severe disease was noted in the mid left circumflex/2nd obtuse marginal artery; however, this was treated with optimal medical therapy.In (b)(6) 2016, dual antiplatelet therapy (dapt) was stopped.The patient continued on aspirin.On (b)(6) 2017, the patient collapsed.Cardiopulmonary resuscitation (cpr) was initiated by a bystander and also by ambulance crew.The patient was transferred to the emergency room.Upon arrival, the patient was unresponsive to cpr and not tolerating airway.Intravenous fluids were started and cpr continued.A chest compression device was used and medication was administered.Agonal breathing was noted, as well as metabolic disturbance not compatible with survival.Resuscitation attempts were stopped and the patient died.It was suspected that the event may have been caused by stent thrombosis.No autopsy was performed.Cause of death was reported as cardiac arrest and ischemic heart disease.There was no additional information provided.

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 cardiac arrest, death and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are a known adverse event 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.

• 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: 6941203
• MDR Text Key: 89008001
• Report Number: 2024168-2017-08142
• 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,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2015
• Device Catalogue Number: 1012464-18
• Device Lot Number: 4040761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: ASPIRIN
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 97