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 Myocardial Infarction (1969); Thrombosis (2100); Ventricular Fibrillation (2130)

Event Date 02/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Five months later a control percutaneous coronary angiography was performed with good result.The patient was prescribed dapt for another 12 months.The patient stopped dapt in (b)(6) 2016.On (b)(6) 2016, the patient entered the cantonal hospital lucerne with an acute stemi.It took only 15 minutes from the entry of the patient in the hospital to the first dilatation of the lesion.A 100% scaffold thrombosis of the proximal absorb segment in the proximal lad was identified.Treatment was performed with an export aspiration catheter to aspirate the thrombus.A control oct was performed which firmly established that approximately 5mm of the proximal part of the absorb did not epithelialize well and that the proximal stent struts were not ingrown but visible.A 3.0x18mm non-abbott drug eluting stent was implanted to fix the thrombus components and proximal struts.The patient is doing well now.When the reported scaffold thrombosis occurred on (b)(6) 2016, the patient was still under marcumar inr 2.2.The patients outcome was good.The patient was prescribed dapt with clopidogrel 75mg for 12 months again.No additional information was provided.(b)(4).The absorb 3.0 x 18 mm scaffold referenced is being filed under a separate manufacturer report number.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 additional relevant information.

Event Description

It was reported that the patient presented with a st-elevated myocardial infarction (stemi).The index procedure on (b)(6) 2015 was to treat a lesion located in the proximal left anterior descending (lad) artery with mild tortuosity and moderate calcification with 100% stenosis.Vessel sizing was performed using optical coherence tomography (oct).The lesion was prepared using a 3.0 x 15 mm non-abbott nc balloon at 10 atmospheres (atm) with the residual stenosis reduced to less than 40%.A small dissection occurred which was treated with implantation of a 3.0 x 28 mm absorb scaffold proximal.A 3.0x18mm absorb was implanted distal.Post-dilatation was performed on both scaffolds using a 3.5 x 15 mm non-abbott nc balloon at 20 atm and a 3.0 x 15 mm non-abbott balloon.Residual stenosis was less than 10%.Thirty minutes post procedure, the patient experienced ventricular fibrillation and scaffold thrombosis was noted thought to be due to late dual anti-platelet therapy (dapt) loading.An oct was performed; however, there was no clear reason visible for the scaffold thrombosis.The physician assumed that the medication was the reason.During intervention, the patient received aspirin and after intervention, the patient received plavix.He supposed that plavix did not yet work after the intervention and he should have given it during the intervention.The thrombosis was treated with aspiration and post-dilation.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The reported patient effects of myocardial infarction, thrombosis and ventricular fibrillation, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu), 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.The reviewer concluded the following: incomplete strut apposition and late initiation of anti-platelet medication have both been demonstrated to contribute to increased risk of thrombosis.Additionally, the angiogram showed kissing balloon post-dilatation being performed through the struts of the lad absorb and into a diagonal side branch.Subsequent oct images of this location demonstrated scaffold strut disruption and mal-apposition, which may have been a contributing factor to thrombosis.Reportedly the scaffold was being used to treat a small dissection.It should be noted that the ifu states: the absorb bvs is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions.It is unknown if the ifu deviation contributed to the reported difficulty.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined that the scaffold malapposition, patient effects and treatment appear to be related to circumstances of the procedure.

Event Description

A review of the cine by an abbott clinical specialist identified incomplete strut apposition and strut disposition on the 3.0 x 28 mm absorb scaffold.

• 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: 6089784
• MDR Text Key: 59502080
• Report Number: 2024168-2016-07778
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012463-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SCAFFOLD: ABSORB 3.0 X 18 MM; SCAFFOLD: ABSORB 3.0 X 18 MM
• Patient Outcome(s): Hospitalization; Required Intervention; Disability