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

Model Number	1012581-26
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The additional devices are being filed under separate medwatch report numbers.(b)(4).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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported failure to seal; however, the subsequent treatment appears to be related to the operational context of the procedure.It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use specifies the rated burst pressure (rbp) 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 patient effect of unrelated death, and the relationship to the product, if any, cannot be determined.In the opinion of the physician, the use of the graftmaster did not cause or contribute to the patient death in any way.The patient's health was declining toward death (mi and perforation) prior to any graftmaster use.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.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a perforation in the left anterior descending coronary artery.The patient presented with a myocardial infarction (mi), and the patient had coded.A 4x19mm graftmaster covered stent was deployed at 15 atmospheres (atms) but failed to seal the perforation.Then, a 3.5x19mm graftmaster covered stent was deployed at 15 atms but failed to seal the perforation.Then, a 3.5x26mm graftmaster covered stent was deployed at 20 atms but failed to seal the perforation.An unspecified stent was attempted, but the patient expired on (b)(6) 2020 due to the mi and perforation.In the opinion of the physician, the use of these graftmasters did not cause or contribute to the patient death in any way.The patient's health was declining toward death (mi and perforation) prior to any graftmaster use.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: 10906138
• Report Number: 2024168-2020-09923
• Device Sequence Number: 19594543
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 11/30/2020
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 8120441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/25/2020
• 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 Age: 84 YR