MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Model Number	1012580-16
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	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier: use after expiration; device code 2017 clarifier: above rbp.
Event or Problem Description
It was reported that the procedure was performed to treat a dissection caused by rotablation in the left circumflex (cx) coronary artery with moderate calcification.The 2.80x16mm graftmaster was implanted at 22 atmospheres and the dissection was sealed.It was noted after use that the device is expired.There were no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that the graftmaster was used past the expiration date.A review of the graftmaster label attached to the lot history record for this lot was conducted indicating a manufacturing date of (b)(6) 2021 with an expiration date (use by date) of (b)(6) 2023.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2023.The expiration date of the product is important for sterility, efficacy, and performance of the device.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, (ifu) states: note the product use by date specified on the package.The ifu deviation contributed to the reported event.The investigation determined the reported improper or incorrect procedure or method (device expiration issue) appears to be related to the use error.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 17087332
• Report Number: 2024168-2023-06039
• Device Sequence Number: 6070102
• Product Code: MAF
• UDI-Device Identifier: 08717648176340
• UDI-Public: 08717648176340
• Combination Product (Y/N): N
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/10/2023

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: 04/30/2023
• Device Model Number: 1012580-16
• Device Catalogue Number: 1012580-16
• Device Lot Number: 1052541
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 54 KG