MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1235250-08

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

Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

On (b)(6) 2016 the patient experienced angina.A 3.5x12 mm absorb gti scaffold was implanted in the right coronary artery (rca) and a 2.5x08 mm absorb gti scaffold was implanted in the diagonal artery.On (b)(6) 2016, the patient presented with a myocardial infarction (mi).Angiography showed a complete occlusion of the diagonal artery and the 2.5x08 mm scaffold.There was no thrombosis in the rca.A 3.0x23 mm xience alpine stent was implanted in the 2.5x08 mm scaffold for treatment.The next morning the patient was brought back to the cath lab; due to the mi from the night before the patient had continuous angina which never completely went away.The diagonal and the right coronary artery (rca) were both open with timi flow.Intravascular (ivus) imaging of the diagonal revealed a vessel diameter of 4.0 mm.As the 3.0x23 mm xience alpine stent implanted the night before had not been post dilated, a 4.0x12 mm nc balloon was used for post-dilatation to address sizing concerns.Ivus imaging of the rca revealed a 4.5mm vessel, also undersized with a 3.5 mm scaffold during the original procedure.As a preventive measure a 4.0mm xience stent was implanted and post-dilated with a 4.5mm nc balloon.The patient is doing fine.There was no issue with the device itself.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A cine was received and reviewed by an abbott vascular physician.The reviewer concluded: the thrombosis of the absorb scaffold in the diagonal artery 1 week post-implant was most likely due to gross under-sizing in what, ultimately by intravascular ultrasound, turned out to be a 4.0mm vessel.There was no thrombosis of the rca scaffold, but this was also grossly undersized and thus treated with a larger diameter xience drug eluting stent.The reported patient effects of angina, myocardial infarction and thrombosis as listed in the absorb gt1 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 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.

• Brand Name: ABSORB GT1 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: 6196653
• MDR Text Key: 63057339
• Report Number: 2024168-2016-09131
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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: 07/28/2017
• Device Catalogue Number: 1235250-08
• Device Lot Number: 6072961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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: 3.5X12 MM ABSORB GTI
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 63