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

Catalog Number 1012462-28

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

Patient Problems Syncope (1610); Angina (1710); Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Nausea (1970); Thrombosis (2100); Stenosis (2263)

Event Date 11/15/2016

Event Type  Death  

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 cine of the procedure was returned and reviewed by an abbott clinical specialist.The reviewer concluded that there was successful stent and scaffold deployment in the lad, both with good result and flow.The reported patient effects of cardiac arrest, death, 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.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.

Event Description

It was reported that the procedure on (b)(6) 2016, was to treat a patient experiencing chronic stable angina with severe coronary artery disease.The proximal and mid left anterior descending artery (lad) had 60% stenosis.It was thought that the proximal lesion was the culprit; therefore a 3.5 x 24 mm non-abbott drug eluting stent was implanted with excellent result.Repeat fractional flow reserve (ffr) indicated hemodynamically severe disease of the mid-lad.Pre-dilatation was performed and a 2.5 x 28 mm absorb scaffold was deployed.Post-dilatation was done with a 3.0 mm balloon with an excellent result.Only some pinching of small septal perforators and diagonal branches were noted, but no dissection was seen and timi 3 flow was achieved.The scaffold seemed well deployed.The patient was transferred to the cardiac care unit overnight.The following day the patient had some nausea, but there were no changes in her electrocardiogram (ecg) and it was thought the cause was the medication (clopidogrel and enoxaparin).The patient was discharged at 11:00 am, after feeling much better.The physician was later informed that once at home, the patient experienced gastrointestinal upset and was given an effervescent antacid powder.The patient lost consciousness and could not be revived.The patient passed away at home that afternoon at 1:30pm.It was confirmed that the patient was given dual antiplatelet drug therapy (dapt) the day she was released.No autopsy was done.The reported cause of death by the physician was acute scaffold thrombosis with acute myocardial infarction, or a malignant ventricular tachyarrhythmia.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: 6170876
• MDR Text Key: 62265475
• Report Number: 2024168-2016-08825
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648156960
• UDI-Public: (01)08717648156960(17)161112(10)5051861
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2016
• Device Catalogue Number: 1012462-28
• Device Lot Number: 5051861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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
• Treatment: STENT: 3.5 X 24 MM SYNERGY (BOSTON SCIENTIFIC)
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 73