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

Catalog Number 1012580-16

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  Injury  

Event Description

It was reported that the patient presented with a free perforation in the right coronary artery.The 3.5x16mm graftmaster covered stent was attempted to be advanced; however, failed to cross due to anatomy.A 2.8x19mm graftmaster was advanced and deployed successfully; however, the perforation was larger than expected.A 2.8x16mm graftmaster covered stent was advanced to the perforation; however, during inflation the device would not inflate even at 20 atmospheres.It was noted the graftmaster met resistance with anatomy during advancement.Therefore, an additional graftmasters 3.5x19mm was attempted to be advanced; however, failed to cross due to anatomy.A 2.8x16mm graftmaster was used to successfully complete the procedure and seal the perforation.There was no adverse patient sequela and no clinically significant in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - above rbp.The additional graftmaster devices referenced in b5 are filed under separate medwatch report numbers.

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.It was reported that the graftmaster was inflated to a maximum pressure of 20 atmospheres (atm).It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use specifies the rated burst pressure (rbp) is 16 atm and clearly states not to exceed the rbp.It is unknown if the exceeded rated burst pressure contributed to the reported event.A conclusive cause for the reported difficulties could not 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.

• 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: 17501827
• MDR Text Key: 320904362
• Report Number: 2024168-2023-08640
• 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,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 08/23/2023
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG