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 Problems Angina (1710); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Perforation (2001); Pericardial Effusion (3271)

Event Date 03/06/2017

Event Type  Injury  

Event Description

It was reported through a research article, identifying the 3.5×28mm absorb bio-resorbable vascular scaffold (bvs) system as follows: a patient presented for a percutaneous coronary intervention (pci) to treat a mildly calcified lesion in the proximal left anterior descending artery (plad) with a 3.5x28mm absorb bio-absorbable vascular scaffold (bvs).Following pre-dilation and deployment of the 3.5×28mm absorb bvs, high pressure post-dilation was performed, after which a perforation, hypotension, chest pain and st elevation were noted.Hemostasis of the perforation was attempted with prolonged balloon dilation, which was unsuccessful, so they implanted a non-abbott covered stent, which resolved the issue restoring blood flow and covering the perforation.The patient was discharged 3 days later.Repeat angiography at 3 months showed patent stents with timi iii flow, and optical coherence tomography (oct) showed good expansion and apposition of the proximal absorb bvs.The patient has remained well 4 years after pci with no major cardiovascular events.Details are listed in the attached article, titled coronary artery perforation after bio-resorbable scaffold implantation treated with a new generation covered stent¿ oct insights please see article for additional information.

Manufacturer Narrative

Date of event: estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant: estimated.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 could not be conducted because the part and lot number were not provided.The reported patient effects of angina, hypotension, perforation, pericardial effusion and myocardial infarction, 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, 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.Article, titled coronary artery perforation after bio-resorbable scaffold implantation treated with a new generation covered stent¿ oct insights.

• 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: 13875718
• MDR Text Key: 288367949
• Report Number: 2024168-2022-03070
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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: 02/28/2022
• 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
• Treatment: 3.0 MM HIRYU NON-COMPLIANT MONORAIL BALLOON; 3.5 MM HIRYU NON-COMPLIANT MONORAIL BALLOON; EBU 4.0 GUIDE CATHETER; ILUMIEN OPTIS PCI OPTIMISATION INTRAVASCULAR IMAGI; SHORT 4.0 MM HIRYU NON-COMPLIANT MONORAIL BALLOON
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 46 YR
• Patient Sex: Male