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

Model Number	1012581-16
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation in the mid left anterior descending (mlad) artery with heavy calcification.The 3.5x16mm graftmaster covered stent was implanted at the perforation; however, the stent failed to seal the perforation.Therefore another 3.5x16mm graftmaster was implanted and the perforation still did not seal.A 2.8x16mm was then implanted and the perforation was noted to not seal.Next a 4x16mm graftmaster stent was attempted to be advanced; however, the 4x16mm graftmaster stent failed to cross the first previously implanted 3.5x16mm graftmaster stent.Therefore the 4x16mm graftmaster stent was removed from the patient.Due to the perforation not being sealed and continuing to ooze, pericardiocentesis was performed and then open heart surgery was performed to patch the perforation.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database did not indicate a lot specific quality issue.A conclusive cause for the reported patient-device incompatibility (failure to seal) could not be determined; however, the reported difficult to advance and subsequent treatment appear to be related to the operational context of the procedure.Patient-device incompatibility (failure to seal the perforation) may be attributed to several factors including, but not limited to, patient anatomical morphology, product size selection, deployment technique (non-central positioning of stent graft over perforation or inadequate overlapping), interference from previously deployed devices, or growth of perforation during deployment.Based on the information provided and without the device to examine, the reported patient-device incompatibility (failure to seal) cannot be confirmed.In addition, it is likely the device interacted with the heavily calcified lesion during advancement, contributing to the reported difficulty to advance/position (crossability).Due to the perforation not being sealed and continuing to ooze, the physician used a catheter for pericardiocentesis, and then open-heart surgery was performed to patch the perforation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional devices referenced in b5 are filed under separate medwatch report numbers.

• 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: 20011130
• Report Number: 2024168-2024-09725
• Device Sequence Number: 17956375
• 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
• Report Date (Section B): 08/19/2024

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: 07/26/2024
• Initial Report FDA Received Date: 08/21/2024
• 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: 83 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG