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

Model Number	1012581-16
Medical Device Problem Codes	Off-Label Use (1494); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.It was reported the procedure was to treat an arterial extravation in a branch off of the left common femoral artery.The 3.50x16mm graftmaster stent was implanted.A coil was additionally implanted to seal the perforation.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use ifu, states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported failure to seal; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Additional Manufacturer Narrative
H6: medical device problem code 1494 clarifier- incorrect anatomy 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 procedure was to treat an arterial extravation in a branch off of the left common femoral artery.The 3.50x16mm graftmaster stent was implanted.A coil was additionally implanted to seal the perforation.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 19840597
• Report Number: 2024168-2024-08897
• Device Sequence Number: 7676011
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: (01)08717648176395(17)250930(10)3102641
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/01/2024

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: 09/30/2025
• Device Model Number: 1012581-16
• Device Catalogue Number: 1012581-16
• Device Lot Number: 3102641
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male