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 Problems Intimal Dissection (1333); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated based on date of article publication.Date of implant has been estimated based on date of first patient enrollment.Alert date has been estimated based on date the article was read.The scafold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: angiographic and midterm outcomes of bioresorbable vascular scaffold for coronary bifurcation lesions.Author- pieter smits, american journal of cardiology 122.12: 2035-2042.Elsevier inc.(dec 15, 2018).The additional patient deaths and malapposed scaffold struts referenced in the article are being filed under separate medwatch report #s.

Event Description

It was reported through a data review of 107 patients between july 2009 and december 2015 identifying absorb bioresorbable vascular scaffolds (bvs) that may be related to major adverse cardiac events of myocardial infarction (mi), target lesion revascularization (tlr), target vessel revascularization (tvr), target lesion failure (stenosis), dissection, thrombosis and hospitalization.Specific patient information is documented as unknown.Details are listed in the attached article, titled "angiographic and midterm outcomes of bioresorbable vascular scaffold for coronary bifurcation lesions".

Manufacturer Narrative

Internal file number - (b)(4).Unique device identifier (udi): in the absence of reported part number, udi cannot be calculated.The scaffold remains in the vessel; however, there was no reported device malfunction and the product was not returned.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of dissection, myocardial infarction, thrombosis 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.Based on the case information, a conclusive cause for the reported patient effects, 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.

• 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
• MDR Report Key: 8358058
• MDR Text Key: 136753421
• Report Number: 2024168-2019-01274
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR