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

Catalog Number 1012463-18

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

Patient Problems Angina (1710); Myocardial Infarction (1969); Stenosis (2263)

Event Date 11/20/2018

Event Type  Injury  

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 of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of angina, myocardial infarction 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.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 that the procedure was to treat the proximal right coronary artery.On (b)(6) 2014, a 3.0 x 18 mm absorb scaffold was implanted; however, on (b)(6) 2018, the patient experienced angina and optical coherence tomography (oct) imaging revealed that there was in-stent restenosis (isr).Additionally, a myocardial infarction was diagnosed.This was treated with a 3.0 x 23 mm xience alpine stent.There was no adverse patient sequela reported.No additional information was provided.

• 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: 8157100
• MDR Text Key: 130161719
• Report Number: 2024168-2018-09620
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012463-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2018
• 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): Hospitalization; Required Intervention; Disability