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 Problems Arrhythmia (1721); Myocardial Infarction (1969); Thrombosis (2100); Heart Failure (2206)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 of the reported device could not be conducted because the part and lot numbers were not provided.The reported patient effects of arrhythmia, myocardial infarction 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 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.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The additional absorb implanted in the lad and referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the patient presented with a non st-elevated myocardial infarction.The index procedure was performed between (b)(6) 2016 and was to treat two vessel disease involving the proximal to mid left anterior descending (lad) artery with 99% stenosis and the mid to distal right coronary artery (rca).Vessel sizing was performed and the diameter was determined to be greater than 2.5mm.A 3.0mm absorb was implanted in the mid lad and a 3.5mm absorb was implanted in the proximal lad.Two 3.5mm absorb were implanted in the mid to distal rca.The patient was placed on dual antiplatelet drug therapy (dapt) consisting of plavix 75mg/day and aspirin 100mg/day.Six months post implantation the patient experienced a st-elevated myocardial infarction (stemi) and subsequently late thrombosis was identified in the lad only.The thrombosis was treated with thrombectomy first then poba.After the procedure the patient experienced heart failure and complete av block.The patient was treated with the implantation of a permanent pacemaker during admission and was ultimately discharged in stable condition.It was confirmed that the patient was compliant in following the dual antiplatelet drug therapy (dapt) after the index procedure.The patient's dapt was changed to brilinta 90mg/day and aspirin 100mg/day.No additional information was provided.

• 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: 6258794
• MDR Text Key: 65026639
• Report Number: 2024168-2017-00532
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• 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: 01/08/2017
• 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: SCAFFOLDS: ABSORB X 3
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 60 YR