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

Catalog Number 1012464-28

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

Patient Problems Angina (1710); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Thrombosis (2100); Cardiogenic Shock (2262); Stenosis (2263); Coma (2417)

Event Date 10/14/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Heart and lung resusitation was performed for 30 minutes without any success and the patient died.An autopsy was performed and thrombosis was noted in the absorb scaffold implanted in the rca, cardiogenic shock and brain oedema were also noted.The cause of death was myocardial infarction.The patient was confirmed to have been compliant in following the dual antiplatelet drug therapy (dapt) after the index procedure.No additional information was provided.The absorb scaffold remains in the patient anatomy.Investigation is not yet complete.A follow up report will be submitted with all 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 on (b)(6) 2016 the patient was admitted with chronic stable angina, functional grade ii.The procedure was to treat a de novo lesion located in the distal right coronary artery (rca) with 66% stenosis.Before the intervention the patient was taking the following medication: lorista 100 mg/day, amlodipine 10 mg/day, fraxiparine - 2 syringes the same time, coplavix 1 pill/day, dinisorb 10 ml/day.On (b)(6) 2016 the patient underwent an intervention to the rca.On angiography 66% stenosis of the rca was noted.Predilatation was performed with a 3.75x20mm non-abbott nc balloon with the residual stenosis reduced to 19%.Implantation of a 3.5x28 mm absorb scaffold using 12 atm.Post-dilatation was performed with a 3.75x20 mm non-abbott nc balloon using 18-20 atm.During the absorb implantation, bradycardia was observed (30 beats per minute), but after post-dilatation of the absorb scaffold, it stopped without any consequences.Control angio noted residual stenosis of the rca was 19%, blood flow timi iii flow, and no spasms of peripheral zone.There was no intravascular ultrasound or optical coherence tomography available in the center so the absorb scaffold could not be confirmed to be fully apposed to the vessel wall.Post-procedure medications prescribed included lorista 50mg per day, coplavix 1 pill (100 mg+75mg) per day, and amlodipine 5 mg, 2 pills, 1 time per day.In the early morning on (b)(6) 2016 the patient was found on the floor of his ward unconscious.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A cine was received and reviewed by an abbott vascular physician.The reviewer stated: from the films supplied, it is questioned whether the scaffold was actually implanted.The final stenosis is 40% and does not appear to be scaffolded, as there are no apparent scaffold markers seen on any of the pictures.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, myocardial infarction, shock and thrombosis, 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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6155204
• MDR Text Key: 61805724
• Report Number: 2024168-2016-08688
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157127
• UDI-Public: (01)08717648157127(17)161102(10)5110461
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2016
• Device Catalogue Number: 1012464-28
• Device Lot Number: 5110461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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: 61 YR
• Patient Weight: 63