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

Model Number	1012583-19
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Unspecified Heart Problem (4454)
Date of Event	08/12/2025
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 captured under separate medwatch numbers.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the proximal left anterior descending (lad).A 3.5x19 mm graftmaster covered stent was implanted at 20 atmospheres (atm) and the perforation appeared sealed post stent placement.The patient was sent to the intensive care unit (icu) and they went into full arrest so the patient was brought back to the cath lab to re-evaluate the perforation.Blushing was seen so an impella pump was placed and the 4.0x19 mm graftmaster covered stent was implanted at 17 atm.The 4.5x19 mm graftmaster covered stent was implanted at 15 atm.Reportedly, the perforation appeared sealed post stent placement; however, the patient ultimately expired due to unspecified complications.The graftmaster devices reportedly did not cause or contribute to adverse events or complications.No additional information was provided.
Additional Manufacturer Narrative
B2: correction to outcomes attributed to ae, added hospitalization-initial or prolonged.
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 received, a conclusive cause for the reported patient-device incompatibility (failure to seal) could not be determined.A conclusive cause for the reported patient effect of hypertension, and the relationship to the product, if any, cannot be determined; however, the subsequent unexpected medical intervention and hospitalization appear to be related to the operational context of the procedure.The reported patient effect of hypertension, as listed in the graftmaster rx coronary stent graft system, instructions for use, is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.The investigation determined that the patient ultimately expired due to unspecified complications confirming the reported death not related to reported adverse event.The graftmaster device reportedly did not cause or contribute to adverse events or complications.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, interference from previously deployed devices, or growth of perforation during deployment.In this case, it is possible that growth of the perforation during deployment may have contributed to the reported patient-device incompatibility (failure to seal); however, based on the information provided, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.B1: adverse event/product problem added product problem b2: outcomes attributed to ae updated from "death" to "required intervention" h1: type of reportable event updated from "death" to "serious injury" h6: health effect - clinical code 4454 was removed; health effect - impact code 1802 was removed; medical device problem code 2993 was removed.
Event or Problem Description
Subsequent to the initially filed reports it was reported that the 4.5x19 mm graftmaster was deployed first.This did not completely seal the perforation and the 4.0x19 mm graftmaster was then implanted and the perforation was thought to have been sealed.The impella pump was placed due to high end diastolic pressure (edp).When the patient was brought back to the cath lab, the 3.5x19 mm graftmaster was deployed.In the physician's opinion, no graftmaster device caused or contributed to the patient death and the patient was declining in health (towards death) prior to use of the graftmaster devices.No additional information was provided.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY COVERED STENT
• 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23137787
• Report Number: 2024168-2025-10277
• Device Sequence Number: 8847160
• Product Code: NIV
• UDI-Device Identifier: 08717648176487
• UDI-Public: (01)08717648176487(17)261031(10)4112941
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 10/20/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012583-19
• Device Catalogue Number: 1012583-19
• Device Lot Number: 4112941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 10/20/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/17/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X19 MM GRAFTMASTER; 4.0X19 MM GRAFTMASTER
• Outcome Attributed to Adverse Event: Required Intervention; Death; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 81 KG