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

Model Number	1012581-19
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the distal left anterior descending (lad) artery with heavy calcification.The 3.5x19mm graftmaster covered stent failed to cross due to the anatomy.It was noted that the stent struts were damaged [flared] with graft material upon removal and the stent was expired.A guideliner was inserted to help and another 3.5x19mm graftmaster covered stent was attempted to be used but failed to cross due to the anatomy as well.There were no other issues noted.A third 2.8x19mm graftmaster covered stent was used that sealed the perforation.There was no adverse patient effect and there was no clinically delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).The additional graftmaster device referenced is being filed under a separate medwatch report number.
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 27-november-2020 with an expiration date (use by date) of 31-october-2022.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2022.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.It is unknown if the ifu deviation contributed to the reported event; however, the graftmaster was intentionally used due to the emergent need.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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: 15969298
• Report Number: 2024168-2022-12563
• Device Sequence Number: 5107152
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: 08717648176401
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1012581-19
• Device Catalogue Number: 1012581-19
• Device Lot Number: 0112741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG