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

Catalog Number 1012464-18

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Aneurysm (1708); Angina (1710); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Stenosis (2263); Diaphoresis (2452)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The reported patient effects of angina, aneurysm, myocardial infarction and restenosis, 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 information reviewed, a conclusive cause for the reported difficulty to deploy and patient effects could not be determined and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Attachment: article - coronary aneurysm formation after bioresorbable vascular scaffold implantation resulting in acute myocardial infarction.

Event Description

The following information was reported from an article titled "coronary aneurysm formation after bioresorbable vascular scaffold implantation resulting in acute myocardial infarction." the elective procedure was to treat an 80% stenosis in the proximal left anterior descending (lad) artery.The patient had been experiencing chest pain and a treadmill test was positive for ischemia.After lesion pre-dilatation, a 3.5 x 18 mm absorb scaffold was implanted.Post dilatation was performed.Final angiographic image showed excellent flow.Intravascular ultrasound (ivus) showed optimal scaffold wall apposition at the proximal area, but suboptimal result over the distal area.Due to the good angiographic result and for fear of deforming the scaffold, no additional post-dilatation was performed.The patient was discharged the following day with dual antiplatelet therapy (dapt).On (b)(6) 2016, the patient began experiencing severe chest pain and profuse diaphoresis.Nitroglycerin was taken, but the pain persisted and the patient was taken to the emergency room.Electrocardiogram was normal, but ck-mb levels were elevated.A non st elevation myocardial infarction was suspected so the patient was given loading doses of dapt and heparin.Angiography and ivus noted a non-significant distal edge restenosis and a small aneurysm immediately after the first diagonal (d1) branch.Pre-dilatation was performed and a stent was implanted followed by post-dilatation, resolving the symptoms.2 days later, the patient was discharged.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: 6608775
• MDR Text Key: 76550024
• Report Number: 2024168-2017-04730
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157103
• UDI-Public: (01)08717648157103(17)161206(10)5120862
• 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: literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2016
• Device Catalogue Number: 1012464-18
• Device Lot Number: 5120862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 62 YR