MAUDE Adverse Event Report: ABBOTT VASCULAR INC. GRAFTMASTER; CORONARY STENT DELIVERY SYSTEM

Model Number	1012580-19
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6- medical device problem code 2017 clarifier: use after expiration manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported the 2.80x19mm graftmaster stent was used after the expiration date.The account confirmed the expiration date prior to use; however as it was an emergency situation, the stent was implanted anyway.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.Reportedly, the 2.80x19mm graftmaster stent was used after the expiration date.It should be noted that the graftmaster rx coronary stent graft system instructions for use states: note the product ¿use by¿ date specified on the package.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use as the device was used after the use by date.As reported, the account confirmed the expiration date prior to use; however, as it was an emergency situation, the stent was implanted anyway.Per the physician the implantation of the stent saved the patient¿s life.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: model number updated from na to 1012580-19.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19010369
• Report Number: 2024168-2024-03936
• Device Sequence Number: 17113872
• Product Code: MAF
• UDI-Device Identifier: 08717648176357
• UDI-Public: (01)08717648176357(17)240229(10)2032241
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 1012580-19
• Device Catalogue Number: 1012580-19
• Device Lot Number: 2032241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown