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 Stenosis (2263); Test Result (2695)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: xience alpine: 3.0 x 33 mm, 2.7 5 x 12 mm, 2.5 x 12 mm, other: absorb gt1: 2.5 x 18 mm, 2.5 x 28 mm.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure on (b)(6) 2016 was to treat a long lesion (70-99% stenosis) in the left anterior descending (lad) artery and 1st diagonal (d1) artery.The patient presented with unstable angina.Pre-dilatation was performed on all lesions reducing the stenosis to less than 40%.A 2.5 x 18 mm absorb gt1 scaffold was implanted in the distal lad and two absorb gt1 scaffolds (3.0 x 12 mm and 2.5 x 28 mm) were implanted in the mid lad.A 3.0 x 33 mm xience alpine failed to cross to treat the proximal lad so additional pre-dilatation was done with a 3.0 x 12 mm non-abbott balloon and a new 3.0 x 33 mm xience alpine and a 2.75 x 12 mm xience alpine were implanted in the proximal lad.A 2.5 x 12 mm xience alpine was implanted in the ostium of the d1.All implants were post-dilated with unspecified balloons, reducing the stenosis to less than 10%.The patient was discharged on dual antiplatelet drug therapy (dapt) of plavix and aspirin.The patient returned for a new procedure on (b)(6) 2017 due to positive stress test (asymptomatic) and it was observed that a restenosis was present in the 3.0 x 12 mm absorb gt1 scaffold in the mid lad.The restenosis was treated with a 2.75 x 12 mm xience alpine and post-dilatation with a 3.0 x 6 mm non-abbott balloon at 16 atmospheres.The patient condition is good.It was confirmed that the patient had been complaint with dapt.No changes were made in the prescribed dapt.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 review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of restenosis, as listed in the absorb gt1 instructions for use, is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.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: 6445764
• MDR Text Key: 71236101
• Report Number: 2024168-2017-02650
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2017
• Device Catalogue Number: 1234300-12
• Device Lot Number: 5082661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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
• Patient Age: 65 YR