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

Catalog Number 1012580-16

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Angina (1710); Cardiac Arrest (1762); Myocardial Infarction (1969); Tachycardia (2095); Thrombosis/Thrombus (4440)

Event Date 07/15/2023

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the mid left anterior descending coronary artery (mlad).After an instantaneous wave-free ratio (ifr) was performed to confirm the lesion area, a 2.5x22mm non-abbott stent was used to treat the lesion; however, a perforation was noted in the left ventricle.A balloon angioplasty was performed with a 2.5x20mm unspecified balloon for seven minutes, but it did not work; therefore, a 2.8x16mm graftmaster was used at 18 atmospheres in the middle of the previous stent to seal the perforation and the patient developed chest pain.An electrocardiogram (ekg) confirmed st elevations without evidence of pericardial effusion which was treated with medication.The patient was hospitalized, and was being monitored; however, the chest pain continued and the patient experienced ventricular tachycardia and cardiac arrest; therefore, cardiopulmonary resuscitation (cpr) was performed.An angiography was performed, which confirmed that the stent was thrombosed.A clot was removed with a non-abbott device and an intravascular ultrasound (ivus) was performed after the clot was removed.The patient is doing well.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.It was reported that the graftmaster was deployed with a maximum pressure of 18 atmospheres (atm).It should be noted in 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.In this case, it is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.The reported patient effects of tachycardia, myocardial infarction and thrombosis are listed in the graftmaster rx coronary stent graft system, instructions for use (ifu) as known patient effects that may be associated with use of a coronary stent in native coronary arteries.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6- device code 2017 clarifier: above rbpna.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: 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: 17484369
• MDR Text Key: 320659299
• Report Number: 2024168-2023-08544
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176340
• UDI-Public: 08717648176340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012580-16
• Device Lot Number: 2062041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 66 KG