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

Model Number	1012581-19
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with a free perforation with extravasation in the circumflex artery.A 3.5x19mm graftmaster covered stent was deployed at 19 atmospheres (atms), but the perforation was not sealed as it was noted the stent deployed proximal to the perforation.A second 3.5x26mm graftmaster was deployed at 19 atms and sealed the perforation.There were no reported adverse patient sequelae and no clinically significant delay reported.No additional information was been provided.
Additional Manufacturer Narrative
H6 - medical device problem code 2017 clarifier - above rbp.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received without a valve loaded within the capsule.The device was received with the capsule partially opened.There was deformation to the distal end of the capsule, appearing as a slight ridge.The handle appeared intact.The device was returned with the end cap/screw gear snap fit connected.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The inner member shaft and spindle hub appeared intact with no evidence of damage.An evolutfx 29mm valve (b)(6) was successfully loaded onto the dcs.On retraction of the capsule via the rotation of the deployment knob, the valve deployed as expected without any difficulty noted.The reported event for unable to deploy could not be confirmed in the analysis.Updated: h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19907046
• Report Number: 2024168-2024-09199
• Device Sequence Number: 17908560
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: (01)08717648176401(17)250930(10)3102641
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/20/2024

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: 1012581-19
• Device Catalogue Number: 1012581-19
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/20/2024
• 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: 75 YR
• Patient Sex: Male