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

Model Number	1012582-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The location of the reported device was not provided; however, when information is received the investigation will be completed.A follow-up report will be submitted with all additional relevant information.The additional graftmaster device referenced is being filed under separate medwatch report number.
Event or Problem Description
It was reported that the patient presented with a free perforation with extravasation in the right coronary artery (rca).A 3.5x19mm graftmaster rx covered stent system was advanced; however, the stent dislodged.An unspecified drug-eluting stent was used to crush the dislodged stent into the proximal rca.An attempt to advance a 4.0x26mm graftmaster rx covered stent system was made, but it did not cross.It was not reported how the perforation was treated.There was no reported clinically significant delay in the procedure.No additional information was provided.
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 identified no other incidents.The investigation was unable to determine a conclusive cause for the reported failure to advance; however, the subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9695980
• Report Number: 2024168-2020-01379
• Device Sequence Number: 19404098
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 12/31/2020
• Device Model Number: 1012582-26
• Device Catalogue Number: 1012582-26
• Device Lot Number: 9012941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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: 76 YR