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); Cardiac Enzyme Elevation (1838); Stenosis (2263)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other absorb rx device is filed under a separate manufacturing report number.

Event Description

It was reported that on (b)(6) 2014, two absorb bioresorbable vascular scaffolds (bvs) were successfully implanted in the mid left anterior descending (lad) coronary artery.On (b)(6) 2017, the patient was admitted to the hospital with angina relieved by nitroglycerine.Elevated troponin was noted and the electrocardiogram showed no acute changes.On (b)(6) 2017, the patient was discharged from the hospital.On (b)(6) 2017, the patient was admitted to the hospital due to angina on exertion.Coronary angiography revealed three vessel coronary artery disease with new lesions in the right coronary artery and lad.Another percutaneous intervention was planned for the lad.On (b)(6) 2017, the patient was admitted to the hospital for pci.Coronary angiography revealed severe restenosis within both lad scaffolds and new disease in the rca.The lad was treated with two drug eluting stents with good results reported.Balloon angioplasty was also performed within the vessels.During the procedure, the patient experienced a lot of chest pain.On (b)(6) 2017, the patient was admitted to the hospital for pci to the rca and three stents were implanted with good reported results.The event resolved.There was no additional information provided regarding this issue.

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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 and the treatment appears to be related to the circumstances of the procedure.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
• 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: 7173786
• MDR Text Key: 96696136
• Report Number: 2024168-2018-00181
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2015
• Device Catalogue Number: 1012463-28
• Device Lot Number: 4070761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 64 YR
• Patient Weight: 93