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

Catalog Number 1234300-12

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

Patient Problems Angina (1710); Thrombosis (2100)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 lot number was not provided.The reported patient effects of angina 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.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 other absorb gt1 is being filed under a separate medwatch report.

Event Description

Updated case details: it was reported that the patient presented with coronary artery disease.The index procedure on (b)(6) 2017 was to treat a lesion in the mid left anterior descending (lad) with mild tortuosity and mild calcification.Vessel sizing was done with optical coherence tomography (oct) and determined to be greater than 2.5mm in diameter.Predilatation was performed with a 3.0x12mm nc trek at 16 atmospheres (atm) with residual stenosis reduced to less than 40%.Two absorb gt1 (3.0x28, 3.0x12) were implanted and post-dilatation was performed with a nc trek 3.25x12 at 26 atm.The final residual stenosis was less than 10%.Oct was performed and confirmed the absorb gt1 scaffolds were fully apposed to the vessel wall.On (b)(6) 2017 the patient developed chest pain and presented to the emergency room.Thrombosis was identified in the absorb gt1 scaffolds and treated with a thrombuster and balloon angioplasty.The patient was confirmed to have been compliant with their dual anti-platelet therapy consisting of plavix.The final patient outcome was good.There was no adverse patient sequela.No additional information was provided.

• 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: 7127146
• MDR Text Key: 95175424
• Report Number: 2024168-2017-09861
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1234300-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• 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: SCAFFOLD: ABSORB GT1 3.0X28
• Patient Outcome(s): Hospitalization; Required Intervention