MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012463-23

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

Patient Problems Angina (1710); Dyspnea (1816); Thrombosis (2100); Heart Failure (2206)

Event Date 09/03/2016

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.The reported patient effects of angina, thrombosis and heart failure, 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.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.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.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The rx absorb.2.5 x 28 mm referenced is being filed under a separate manufacturer report number.

Event Description

It was reported that the procedure on (b)(6) 2015 was to treat an 80% stenosis in the proximal to mid left anterior descending (lad) artery.The patient presented with unstable angina.Vessel sizing done with intravascular ultrasound (ivus) and the mid lad was 2.75 mm and proximal lad was 3.3 mm.The mid lad was pre-dilated with a 2.5 x 15 mm non-compliant (nc) balloon and the proximal lad was pre-dilated with a 2.75 x 15 mm nc balloon, reducing the stenosis to less than 30%.A 2.5 x 28 mm absorb scaffold was implanted in the mid lesion and a 3.0 x 23 mm absorb scaffold was deployed in the proximal lesion.Post-dilatation was performed on both scaffolds with a final angiographic residual stenosis of less than 10%.Ivus was used to confirm the scaffolds were fully apposed to the vessel wall.The patient was discharged on dual antiplatelet therapy (dapt) of brilinta and aspirin.A few months later, the patient was traveling and stopped taking dapt.The patient returned on (b)(6) 2016 due to chest pain and dyspnea.Thrombosis was found in the scaffolds complicated with heart failure symptoms (ejection fraction 30).The thrombosis was aspirated several times for treatment.No additional intervention was performed.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: 5992151
• MDR Text Key: 56099991
• Report Number: 2024168-2016-06586
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157035
• UDI-Public: (01)08717648157035(17160608(10)4121261
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2016
• Device Catalogue Number: 1012463-23
• Device Lot Number: 4121261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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: SCAFFOLD: RX ABSORB 2.5 X 28 MM
• Patient Outcome(s): Hospitalization; Required Intervention