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 10/15/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event, implant date: estimated dates.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.There was no reported device malfunction and the products were not returned.A review of the lot history record 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.A conclusive cause for the reported patient effect and the relationship to the product, if any, could not be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Literature attachment: meta-analysis comparing outcomes after everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with acute coronary syndromes.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

It was reported through a research article identifying absorb bioresorbable vascular scaffold (bvs) that may be related to cardiac/all cause death.Average patient age and majority gender studied was identified.Details are listed in the attached article, titled meta-analysis comparing outcomes after everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents in patients with acute coronary syndromes.

• 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: 7423033
• MDR Text Key: 105212651
• Report Number: 2024168-2018-02665
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• 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: 04/02/2018
• 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: 57 YR