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

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

Patient Problem Death (1802)

Event Date 05/01/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).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 and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effect of death, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Literature attachment: everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the (b)(6) registry ((b)(6)).The additional adverse patient effects are being filed under a separate medwatch report#.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

The following information was reported through a research article titled: everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the (b)(6) registry ((b)(6)) it was reported that a total of 3231 consecutive patients of the prospective, observational, multicentre (b)(6) registry ((b)(6)) undergoing absorb implantation between november 2013 and january 2016 were analyzed.Major adverse cardiac events (mace) included death, target vessel revascularization, and myocardial infarction (mi) and target lesion failure (tlf) included cardiac death, target vessel mi, and target lesion revascularization.Of all patients, 51.5% presented with acute coronary syndrome.Predilatation was performed in 91.5% and post-dilatation in 71.9% of the treated lesions.Procedural success was 98.9%.After 6 months, mace were documented in 4.1% and tlf in 2.4%.Details are listed in the attached article.

• 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: 6876494
• MDR Text Key: 86631708
• Report Number: 2024168-2017-07580
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 61 YR