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

Lot Number 6082961

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

Patient Problem Thrombosis (2100)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Udi#: in the absence of a reported part number, the udi cannot be calculated.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.The reported patient effects of thrombosis 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.A review of the lot history record and complaint history of the reported lot could not be conducted because the part 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.Mw5077391 sus voluntary event report.

Event Description

It was reported that the pt had three abbott absorb bioabsorbable scaffolds placed on (b)(6) 2017 (x2 to lad and x1 to circumflex artery).She was found to have a stent thrombosis of the bioabsorbable scaffold in the mid left circumflex coronary artery and required a repeat percutaneous intervention for add'l stent placement.

• 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# 3004742046; 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: 7598581
• MDR Text Key: 111056939
• Report Number: 2024168-2018-04453
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/13/2018

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 Lot Number: 6082961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/13/2018
• 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): Required Intervention