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 Angina (1710); Ischemia (1942); Stenosis (2263); Test Result (2695)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The patient was sent for an angiogram and a significant stenosis was discovered in the mid lad.The stenosis was exactly mid-way through the implanted absorb.An optical coherence tomography (oct) catheter was attempted to be advanced past the lesion; however, the lesion was too tight so pre-dilatation was performed in the restenosed area.An oct catheter was attempted again to pass through the lesion.Pull back was successful.On oct there appeared to be neointimal proliferation mid way through the scaffold.The case was finished with the implantation of a 3.0x33mm xience stent across the entire scaffold.Final oct was performed and showed a successful outcome.The patient is doing well.The patient was confirmed to have been compliant with their dapt regime.No additional information was provided.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 stable angina.The index procedure on (b)(6) 2016 was to treat a concentric lesion located in the mid left anterior descending (lad) with mild tortuosity and 70% stenosis.Vessel sizing was performed with a visual estimate plus the use of nc balloons and was determined to be greater than 2.5mm.No intravascular imaging was performed during the index procedure.Predilatation was performed with a 2.5x20 mm non-abbott balloon and the residual stenosis was reduced to less than 40%.A 3.0x28mm absorb was implanted and post-dilatation was performed with a 3.5x15mm non-abbott nc balloon with 16 atmospheres (atm).The final angiographic residual stenosis was less than 10%.Acute procedure had good outcome.Reopro bolus was given.The patient was discharged on asprin and ticagrelor.The patient presented 4-6 weeks later at follow-up consultation experiencing shortness of breath which the physician thought was likely an adverse drug reaction due to ticagrelor.The patient's dual anti-platelet therapy (dapt) regime was changed to aspirn and clopidogrel; however, the patient's shortness of breath did not resolve.On (b)(6) 2016, the patient presented with classic chest pain (exertional angina).A stress echo was performed which was positive.

Manufacturer Narrative

(b)(4).Product performance engineering reviewed the incident information; however, 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.Cines were received and reviewed by an abbott vascular physician who concluded the following: satisfactory initial absorb implantation with restenosis at 8 months post implant, with appearance similar to that seen historically with metallic drug eluting stents.No specific device related failure or complications.No evidence for thrombosis.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.The reported patient effects of angina, ischemia and restenosis, 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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Manufacturer Narrative

(b)(4).Correction: the g4 date was filed incorrectly as 01/14/2017 on medwatch follow-up #1.The correct date should have been 02/14/2017.

• 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: 6159879
• MDR Text Key: 62079631
• Report Number: 2024168-2016-08779
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Catalogue Number: 1012463-28
• Device Lot Number: 5093061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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): Hospitalization; Required Intervention