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

Catalog Number 1012463-28

Device Problem Break (1069)

Patient Problems Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263); Prolapse (2475)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The 3.5 x 18 mm rx absorb scaffold is being filed under a separate manufacturer report number.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional 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.International journal of cardiovascular imaging, bioresorbable vascular scaffold fracture in the overlapping zone as cause of accelerated nethoatherosclerosis and in-scaffold very-late thrombosis.

Event Description

It was reported through a research article identifying two absorb that may be related to a non st-elevated myocardial infarction (nstemi), thrombosis and scaffold fracture.It was reported that the patient underwent coronary angiography for non st-elevated myocardial infarction (nstemi) showing a total occlusion of the circumflex artery (cx).Following pre-dilatation with a 2.5 balloon, two absorb scaffolds (3.0x28; 3.5x18) were implanted from distal to proximal overlapping.Fourteen months later, while the patient was under single antiplatelet therapy for 1 month, coronary angiography was performed after a recurrent nstemi, showing a sub-occluded circumflex, with evidence of in-scaffold thrombosis.Optical coherence tomography (oct) was performed and revealed a scaffold fracture in the overlap zone.There was a thin-cap fibroatheroma, mainly composed of lipd-rich tissue (highly suggestive of accelerated neo-atherosclerosis) with evidence of plaque rupture and a large burden of thrombus.A second-generation everolimus drug eluting stent (3.0x23mm) was implanted and post-dilated with excellent angiographic and oct result.No additional information was provided.

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 numbers were not provided.The reported patient effects of myocardial infarction, thrombosis and restenosis, 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.Based on the information reviewed, there is no indication of a product quality issue.The investigation was unable to determine a conclusive cause for the reported patient effects; however the reported scaffold discontinuities and treatment appears to be due to circumstances of the procedure.

• 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: 5991780
• MDR Text Key: 56098310
• Report Number: 2024168-2016-06572
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• 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: 11/08/2016
• 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: 3.5 X 18 MM RX ABSORB SCAFFOLD
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR