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

Model Number	1012580-26
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.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.The patient expired two days post procedure of multiple organ system failure due to declining health.The investigation determined the reported difficulties appear 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; however, the subsequent treatments appear 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 presented in declining health with a free perforation in the left anterior descending (lad) artery.A 2.8x26mm graftmaster covered stent was advanced but due to the calcified and difficult anatomy, and interaction with a previously implanted stent, the graftmaster covered stent dislodged from the delivery system and was embedded in the coronary artery.Subsequently, the previously placed stents were re-dilated with a larger balloon at higher pressures, and a guideliner was used to successfully deliver a 3.5x26mm graftmaster covered stent which sealed the perforation.The patient expired two days post procedure of multiple organ system failure due to declining health.Per the physician, the graftmaster stents did not cause or contribute to the patient's declining health or death.There was no reported clinically significant delay in the procedure or therapy.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
• MDR Report Key: 12712376
• Report Number: 2024168-2021-09696
• Device Sequence Number: 17319444
• Product Code: MAF
• UDI-Device Identifier: 08717648176364
• UDI-Public: 08717648176364
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 04/30/2023
• Device Model Number: 1012580-26
• Device Catalogue Number: 1012580-26
• Device Lot Number: 1052541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 78