MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Catalog Number	1012581-19
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	03/04/2024
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 graftmaster devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left main to proximal left anterior descending (lad) coronary arteries.The 4.0x19 mm graftmaster covered stent was implanted in the ostial lad, a 3.5x19 mm graftmaster was implanted in the left main coronary artery and a 2.8x19 mm graftmaster was implanted in the proximal lad.Reportedly, the devices were implanted without issue but the perforation was not sealed.The patient developed multiple episodes of ventricular fibrillation, cardiopulmonary resuscitation (cpr) was performed, and the patient was shocked and medication given.However, the patient reportedly expired due to ventricular fibrillation and uncontrolled perforation.In the physician's opinion, the patients health was declining towards death prior to use of the graftmaster devices and the graftmaster devices did not cause or contribute to the patient death.Although requested, very few details were received; therefore, the relationship, if any, of the graftmaster devices to the reported patient effects are unknown.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Lhr (lot history record) and exception 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.The reported patient effect of ventricular fibrillation is listed in the graftmaster rx coronary stent graft system, instructions for use, as known patient effects that may be associated with use of a coronary stent in native coronary arteries.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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Additional Manufacturer Narrative
H6: medical device problem code 2017 - used above rated burst pressure added.H6: investigation findings code 4248 added.H6: investigation conclusions code 18 added.It was reported that the 3.5x19 mm graftmaster was implanted at 20 atm.It should be noted the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use (ifu), specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.It is unknown if the ifu deviation contributed to the reported event.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left main to proximal left anterior descending (lad) coronary arteries.The 4.0x19 mm graftmaster covered stent was implanted in the ostial lad, a 3.5x19 mm graftmaster was implanted in the left main coronary artery and a 2.8x19 mm graftmaster was implanted in the proximal lad.Reportedly, the devices were implanted without issue but the perforation was not sealed.The patient developed multiple episodes of ventricular fibrillation, cardiopulmonary resuscitation (cpr) was performed, and the patient was shocked and medication given.However, the patient reportedly expired due to ventricular fibrillation and uncontrolled perforation.In the physician's opinion, the patients health was declining towards death prior to use of the graftmaster devices and the graftmaster devices did not cause or contribute to the patient death.Although requested, very few details were received; therefore, the relationship, if any, of the graftmaster devices to the reported patient effects are unknown.Subsequent to the initially filed reports, it was reported that the 4.0x19 mm graftmaster was implanted at 15 atmospheres (atm), the 3.5x19 mm graftmaster was implanted at 20 atm and the 2.8x19 mm graftmaster was implanted at 16 atm.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 19007988
• Report Number: 2024168-2024-03920
• Device Sequence Number: 8464321
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: (01)08717648176401(17)250228(10)3032141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/29/2024

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: 02/28/2025
• Device Catalogue Number: 1012581-19
• Device Lot Number: 3032141
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 04/17/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/12/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4.5X19 MM GRAFTMASTER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 53 KG