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

Model Number	1012584-19
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
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 identified no other incidents.The investigation determined a conclusive cause for the reported inflation issues/failure to deploy/ activation failure including expansion failures could not be determined.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 patient presented with a free perforation with extravasation in the saphenous vein graft to circumflex artery.A 4.8x19mm rx graftmaster covered stent was advanced without issue but unable to deploy at all.Then 4 rx graftmasters (1 - 4x19mm, 1 - 3.5x19mm, and 2 - 4.5x19mm) were deployed at 15 atmospheres and the perforation sealed successfully.All five covered stents were required to seal the large perforation.The covered stents did not cause or contribute to complications or adverse events.There were no device issues with any of the five covered stents and they all worked as intended.There were no reported adverse patient sequelae and no clinically significant delay.No additional information was reported.

• 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: 10498075
• Report Number: 2024168-2020-07431
• Device Sequence Number: 3055555
• Product Code: MAF
• UDI-Device Identifier: 08717648176517
• UDI-Public: 08717648176517
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 09/05/2020

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: 08/31/2021
• Device Model Number: 1012584-19
• Device Catalogue Number: 1012584-19
• Device Lot Number: 9092541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/05/2020
• 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: 68 YR
• Patient Weight: 95