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 Aneurysm (1708)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other absorb device is 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

It was reported that in 2016, the patient underwent a coronary procedure, with implantation of an absorb bioresorbable vascular scaffold (bvs) in the mid right coronary artery (rca) and an absorb bvs in the circumflex (cx) artery.Two years post procedure, the patient presented with symptoms and it was noted that the patient had a significant aneurysm in the mid rca and some aneurysmal appearance in the cx.No additional information was provided.

Manufacturer Narrative

(b)(4).The unique device identifier (udi) is unknown because the part and lot numbers were not provided.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 could not be conducted because the part and lot numbers were not provided.The reported patient effect of aneurysm 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, cannot be determined.There is no indication of a product quality issue with respect to the 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: 7485665
• MDR Text Key: 107311249
• Report Number: 2024168-2018-03300
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• 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: 05/16/2018
• 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): Other