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); Myocardial Infarction (1969); Perforation (2001); Thrombosis (2100)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple attempts to open the lad were made with multiple balloon angioplasties and aspiration thrombectomy.Aggressive dilatation caused a class-iii perforation, which was sealed with a 2.8x19 mm covered-stent and post-dilated with a 3.0 noncompliant balloon.Timi-iii flow was restored despite diffuse lad disease.Residual stenosis was 70% and 50% in the dlad and mlad, respectively.After 72 hours, a second-look angiography using a 6f radial approach showed a patent lad, well expanded stent/scaffolds, and diffuse lad disease with dlad dissection and residual stenosis in the proximal lad.Oct of the mlad and dlad showed intramural hematoma.Angiogram of the coronary arteries during the third angiography showed patent lumen with well expanded stents/scaffolds.Oct of the lad, mlad, and dlad was 0, 50, and 40 percent respectively.The patient was kept on gpiib/iiia inhibitors for another 24 hours, with ticagrelor instead of clopidogrel.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 is being filed under a separate medwatch report.Literature attachment: a case of subacute bioresorbable vascular scaffold thrombosis, what was wrong? the absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

The following information was reported through a research article titled: a case of subacute bioresorbable vascular scaffold thrombosis, what was wrong? it was reported that the patient presented to the emergency department complaining of typical angina.Electrocardiography (ecg) showed normal sinus rhythm with non-specific st-t wave changes.Echocardiography returned normal results.Coronary angiography using a 6f right radial approach showed mid (mlad) to distal lad (dlad) lesions with 75% and 70% stenosis, respectively, and diffuse dlad disease reaching the apex.The lesions were pre-dilated with a 2.5x20 mm balloon and stented with an absorb (3.0x28 mm) in the mlad and 2.5x28 mm absorb in the dlad.Post-dilatation with 3.0 and 3.5 non-compliant balloons was performed in the mid and distal scaffolds.Optical coherence tomography (oct) confirmed good apposition of both scaffolds, no residual stenosis in the mlad and diffuse dlad disease.The patient was kept on dual antiplatelet therapy (dapt) consisting of aspirin and clopidogrel.Six days later, the patient presented with continuous mild chest pain and an ecg showed t-wave inversion in the anterolateral leads and had elevated troponin i (8.817 ng/ml).The patient was diagnosed with non-st elevation myocardial infarction.The next day, coronary angiography showed in-scaffold thrombosis with timi-0 flow in the mlad where the 3.0x28mm absorb scaffold was implanted.

Manufacturer Narrative

Internal file number - (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, myocardial infarction, perforation and thrombosis, 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 and related record review, 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.

Event Description

Additional information: the reported dissection in the distal left anterior descending artery was treated with balloon dilatation and the hematoma was treated with a 2.5x28mm bioresorbable vascular scaffold.

• 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: 7180845
• MDR Text Key: 96935700
• Report Number: 2024168-2018-00271
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2016
• Device Catalogue Number: 1012463-28
• Device Lot Number: 5012661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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
• Patient Age: 42 YR
• Patient Weight: 109