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

Catalog Number 1234350-28

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

Patient Problems Intimal Dissection (1333); Thrombosis (2100)

Event Date 11/10/2016

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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of dissection 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 and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The nc trek 3.0x15 referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat an occluded left anterior descending artery.The patient presented with an st elevated myocardial infarction (stemi).Pre-dilatation was performed with a 2.5 nc trek balloon catheter and then a 3.5 x 15 mm nc trek balloon catheter.After the second pre-dilatation of the 3.5 x 15 mm nc trek, a dissection occurred.A 3.5 x 28 mm absorb gt1 scaffold was deployed at 16 atmospheres which covered the dissection and post-dilatation was performed with a 3.75 x 15 mm nc trek balloon catheter.Optical coherence tomography (oct) was performed which showed a dissection proximal to the scaffold.There was no malapposition of the scaffold.There was also thrombus observed in a distal side branch.It is unknown if the thrombus occurred before the procedure as the patient presented with an mi or if it occurred due to the dissection.A xience stent was implanted to cover the dissection overlapping the scaffold 1 mm.Oct was again performed and the scaffold was still apposed to the vessel wall.The results were good and the patient is doing fine.There was no clinically significant delay in the procedure.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: 6117571
• MDR Text Key: 60542917
• Report Number: 2024168-2016-08184
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212901
• UDI-Public: (01)08717648212901(17)161110(10)5111761
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/21/2016

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 Expiration Date: 11/15/2016
• Device Catalogue Number: 1234350-28
• Device Lot Number: 5111761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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): Required Intervention