MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

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

Patient Problem Stenosis (2263)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that 31 consecutive patients treated with absorb-bvs underwent a structural and functional evaluation of the coronary arteries at the 5-year follow-up.Patients were selected from a multicenter registry of consecutive absorb-bvs recipients and the present analysis reports the imaging and vasomotor reactivity testing results of the 31 patients at =5 years post implant.Those patients who had <5 years follow-up from the implantation time point have been reported in a separate analysis.A total of 5 patients underwent new percutaneous coronary intervention (pci), 3 of whom were performed on scaffolded arteries.A late thrombosis of the device and a restenosis at 6 months of follow-up were described.The follow-up was 60.5 ± 4.6 months.For this patient, restenosis of the device occurred and percutaneous coronary intervention (pci) was performed.Please see attached article, titled 'structural and functional evaluation of coronary arteries treated with absorb bioresorbable vascular scaffold at 5-year follow-up'.

Manufacturer Narrative

Date of event has been estimated as (b)(6) 2022, 5 years post index procedure when stent was implanted.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The summary of patient data and the data for the other 4 patients referenced in the article are being filed under separate medwatch report #s.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.Attachment: article titled, 'structural and functional evaluation of coronary arteries treated with absorb bioresorbable vascular scaffold at 5-year follow-up.

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effect of restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) 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; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16103705
• MDR Text Key: 306717849
• Report Number: 2024168-2023-00169
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• 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): Required Intervention; Hospitalization