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 Angina (1710); Cardiac Arrest (1762); Stroke/CVA (1770); Dyspnea (1816); Myocardial Infarction (1969); Thrombosis (2100); Ventricular Tachycardia (2132); Respiratory Failure (2484)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.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 the procedure on (b)(6) 2016 was to treat an 80% stenosis in the proximal left anterior descending (lad) artery.The patient presented with unstable angina.Pre-dilatation was performed with a 3.0 x 10 mm non-abbott balloon, reducing the stenosis to less than 40%.A 3.5 x 18 mm absorb scaffold was deployed at 12 atmospheres and post-dilated with a 2.5 x 12 mm nc trek with a final residual stenosis of less tan 10%.The patient was doing fine and was discharged the following day.On (b)(6) 2017 the patient returned with chest pain and breathlessness which had been occurring 3 to 4 hours.Angiography diagnosed with a myocardial infarction and scaffold thrombosis.Thrombosuction was successfully performed, but the patient developed cardiac arrest.Cpr was started and the patient developed ventricular tachycardia for which cardioversion was applied 4 times.The patient was resuscitated successfully and amiodarone infusion started.Balloon angioplasty was done with several balloons, achieving timi iii flow.The patient was intubated and connected with mechanical ventilator support and transferred to intensive care unit.Magnetic resonance imaging (mri) brain scan showed large left infarct.Neurologist consultation was done with advise for a treatment plan.The patient was hemodynamically stable and discharged on (b)(6) 2017, left under medical management.It was confirmed that the patient had been compliant with dual antiplatelet drug therapy (dapt) after the initial procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.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 angina, cardiac arrest, cerebrovascular accident, myocardial infarction, thrombosis 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.A cine was received and reviewed by an abbott vascular clinical specialist who concluded that the initial procedure was to treat a focal stenosis in the proximal left anterior descending (lad) with post stenotic dilation of the vessel distal to the stenosis.The lesion was not pre-dilated.The scaffold was positioned and expanded, total deployment time approximately 40 seconds.Throughout the deployment sequence there was a focal area of under expansion mid-scaffold.In the next to last sequence there was a short balloon dilatation catheter positioned at the proximal end of the scaffold, but inflation was not documented.Final angiogram showed the scaffold well expanded proximal and distal with an irregular appearance along the length of the scaffold and a residual unexpanded area mid scaffold.The patient returned on 4/10/2017 with thrombotic occlusion of the scaffold which was treated with balloon dilatation and thrombectomy.Post thrombectomy there continued to be under-expansion of the scaffold.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 the 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: 6574153
• MDR Text Key: 75400879
• Report Number: 2024168-2017-04230
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2017
• Device Catalogue Number: 1012464-18
• Device Lot Number: 6083061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 43 YR
• Patient Weight: 80