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

Model Number	1012582-19
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effect of death, as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.Per the physician, the patient death is unrelated to the graftmaster stent.The investigation was unable to determine a conclusive cause for the reported failure to seal.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the patient was admitted, in guarded condition, for treatment of a complex lesion of the left anterior descending (lad) artery and circumflex (cx) artery.The decision was made to use a mini crush technique.A 4.0 x 22 mm non-abbott stent was deployed in the cx, with approximately 2-3 mm in the left main.After deployment and before the stent was crushed, angiogram demonstrated a perforation.The patient became hypotensive and had complaints of chest discomfort.Medication was administered and a dilatation catheter balloon was inflated to tamponade the perforation.The 4.0 x 19 mm graftmaster stent was deployed, approximately 2-3 mm beyond the proximal margin of the previously implanted stent, and the perforation was sealed.Intravascular ultrasound of the left main to the cx demonstrated the graftmaster stent to be well deployed and that the non-abbott stent was the only part that was covering the origin of the lad.The decision was made to continue the crushing technique; however, angiogram demonstrated recurrent perforation and the patient status declined.Dilatation catheter balloons were advanced and inflated to tamponade the perforation.Doppler ultrasound demonstrated pericardial effusion and the patient was hypotensive.Pericardiocentesis was performed, with some fluid removed and decreasing the size of the pericardial effusion.Despite aggressive advanced cardiovascular life support (acls) with intubation, cardiopulmonary resuscitation (cpr) and multiple medications, refractory hypotension remained.When cpr was about to be discontinued, angiogram was performed and noted no residual perforation in the cx, but there was no flow in the lad.The non-abbott stent was crushed as planned and flow was restored down the lad.Although additional cpr was performed, spontaneous coronary rhythm was not restored and the patient's blood pressure was not restored.After approximately 30 minutes of acls, the patient died the day of the procedure.Per physician, the pericardial effusion, requiring intervention, and patient death are unrelated to the graftmaster stent.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: 14837052
• Report Number: 2024168-2022-06921
• Device Sequence Number: 2382733
• Product Code: MAF
• UDI-Device Identifier: 08717648176456
• UDI-Public: 08717648176456
• 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: 2022
• 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): 06/27/2022

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: 10/31/2022
• Device Model Number: 1012582-19
• Device Catalogue Number: 1012582-19
• Device Lot Number: 0112341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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: 89 YR
• Patient Sex: Male
• Patient Weight: 79 KG