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

Model Number	1012580-26
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiogenic Shock (2262); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a perforation of a lesion in the proximal left anterior descending (plad) artery.Balloon tamponade was initially started for 5 minutes.There was persistent leaking in the plad and the 2.8x26mm graftmaster covered stent was implanted at 14 atmospheres (atms) with the aid of a 6french (f) guideliner; however, there was persistent bleeding.With great difficulty, a compliant balloon was advanced through the graftmaster to further post dilate the stent.Suspect active bleeding was due to lack of stent apposition due to under deployed stents from before.Then used another 3.0mm non-compliant balloon to further post dilate the graftmaster stent at high pressures.Subsequent angiography revealed resolution of bleeding.During this time the patient was having worsening cardiogenic shock and placed an impella catheter.There were no further attempts at recanalization of this heavily stented artery and the patient was transferred to intensive care unit (icu) in critical condition.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 clarifier- failure to follow steps / instructions.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 identified no similar complaints from this lot.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use (ifu), states; deploy the stent graft slowly by pressurizing the delivery system in 2-atm increments, every 5 seconds, until the stent graft is completely expanded.A conclusive cause for the reported patient-device incompatibility (failure to seal the perforation and wall apposition) could not be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Patient-device incompatibility (failure to seal the perforation and wall apposition) 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.It was reported that suspect active bleeding was due to lack of stent apposition due to under deployed stents from before.In this case, it is also possible that growth of the perforation during deployment may have contributed to the reported patient-device incompatibility (failure to seal/leak) and the anatomical conditions and/or previously implanted stents may have contributed to the reported patient-device incompatibility (wall apposition); however, based on the information provided and without the device to examine, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Additional information: d4 - model # added.Corrections: d1 - brand name updated.D3 - name updated.D3 - address, city, postal code updated.H6: medical device problem code 2682 - was added.H6: health effect - code 4582 was removed, health effect - clinical code 2262 and health effect - impact code 4607 were added.

• 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: 19469812
• Report Number: 2024168-2024-06648
• Device Sequence Number: 3394516
• Product Code: MAF
• UDI-Device Identifier: 08717648176364
• UDI-Public: (01)08717648176364(17)250430(10)3052441
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/02/2024

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: 04/30/2025
• Device Model Number: 1012580-26
• Device Catalogue Number: 1012580-26
• Device Lot Number: 3052441
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2023
• 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: 3.0MM NON-COMPLIANT BALLOON.; 6F GUIDELINER.; HI-TORQUE WHISPER EXTRA SUPPORT.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male