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

Catalog Number 1234300-18

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 10/12/2017

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.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.

Event Description

It was reported that the patient presented with progressive angina on exertion.The procedure on (b)(6) 2016 was to treat a de novo lesion located in the proximal left anterior descending (lad) artery which was narrow and stenosed.Pre-dilatation was performed, with a 3.5x15mm balloon with residual stenosis less than 40% and a 3.0x18mm absorb gt1 was implanted at 16 atmospheres.Post-dilatation was performed with a 3.5x15mm non-abbott nc balloon, with residual stenosis less than 10%.However, no optical coherence tomography (oct) was performed to confirm whether the scaffold was fully apposed to the vessel wall.On (b)(6) 2017 the patient presented with chest pain experienced during biking.Oct was performed and the absorb gt1 scaffold was noted to have restenosis; however, the distal part of the scaffold had extra stenosis.The restenosis was treated with the implantation of a non-abbott stent (3.5x18) and post-dilatation with a 3.5x12 nc balloon at 20 atmospheres.The patient was reportedly taking the following medications: aspirin 100mg-qd, plavix 75mg-qd, amlodipin/olmesartan 5/20mg-qd, atorvastatin 40mg-qd and was confirmed to have had good compliance to their dual anti-platelet therapy.The patient will continued to be followed.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: 7190390
• MDR Text Key: 97294186
• Report Number: 2024168-2018-00368
• 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: 01/15/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1234300-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/15/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR