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

Model Number	1012584-16
Medical Device Problem Codes	Off-Label Use (1494); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	03/29/2021
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 did not indicate a lot specific quality issue.It should be noted that the graftmaster rapid exchange (rx) coronary stent graft system, domestic, instructions for use (ifu) states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts.It is unknown if the ifu deviation directly caused or contributed to the reported event.The reported patient effect of embolism, as listed in the graftmaster rx coronary stent graft system ifu, is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported failure to seal the aneurysm.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.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Na.
Event or Problem Description
It was reported that the procedure was performed to treat an aneurysm in the distal right coronary artery (rca).Four non-abbott endovascular coils were implanted in the aneurysm.A non-abbott covered stent was advanced; however, it was unable to cross to the target site and was removed.Two overlapping graftmaster stents were implanted to exclude the aneurysm and promote flow into the right posterior descending artery (pda).Angiography noted minimal flow into the aneurysm.Post dilatation was performed to seal the residual flow; however, one graftmaster stent embolized into the aneurysm.There were no attempts made to remove the embolized graftmaster; however, an additional coil was placed mid vessel to occlude flow into the coronary aneurysm.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: 11728557
• Report Number: 2024168-2021-03540
• Device Sequence Number: 17003552
• Product Code: MAF
• UDI-Device Identifier: 08717648176500
• UDI-Public: 08717648176500
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/26/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1012584-16
• Device Catalogue Number: 1012584-16
• Device Lot Number: 0013041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/26/2021
• 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 Age: 59 YR
• Patient Weight: 47