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

Model Number	1012581-16
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported the procedure was to treat a perforation in the distal circumflex (cx)artery.The 2.80x16mm rx graftmaster stent delivery system (sds) was advanced however the stent dislodged from the balloon in the mid cx.The stent graft had to be deployed where it dislodged outside the target lesion.Another 2.80x16mm graftmaster was advanced and the stent graft deployed in the distal cx however the perforation was not sealed.A 3.50x16mm graftmaster was also deployed in the distal cx however again the perforation was not sealed.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.Based on the 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.D9 - device available for evaluation updated from ¿yes¿ to ¿no¿.

• 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: 19448190
• Report Number: 2024168-2024-06490
• Device Sequence Number: 20967363
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: (01)08717648176395(17)260131(10)4021341
• 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): 12/05/2024

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: 01/31/2026
• Device Model Number: 1012581-16
• Device Catalogue Number: 1012581-16
• Device Lot Number: 4021341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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: 74 YR
• Patient Sex: Male