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

Model Number	1012583-16
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	03/05/2020
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 similar incidents from this lot.It was reported that the rx graftmaster covered stent was deployed at a maximum pressure of 12 atmospheres (atm).It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use (ifu) specifies: deploy the stent graft slowly by pressurizing the delivery system in 2-atm increments, every 5 seconds, until the stent graft is completely expanded.Fully expand the stent graft by inflating to nominal pressure at a minimum.The ifu specifies the nominal pressure is 15 atmospheres (atm).It is unknown if the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported failure to seal.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other additional 3 graftmasters are being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a perforation in the left anterior descending artery.Two graftmaster stents (4.50x16mm and 4.0x16mm) were implanted but they failed to seal the perforation due to leaks in the graft.A 4.0x16mm graftmaster stent was opened but it was then noted that the perforation had self-sealed, so it was not used.As the patient was being transferred, he started bleeding again.Two more graftmaster stents (4.0x16mm and 4.0x16mm) were deployed but also failed to seal the perforation due to graft leaks and the patient died.Per the physician, the cause of death was the perforation and shock.No additional information was provided.

• 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: 9916334
• Report Number: 2024168-2020-03263
• Device Sequence Number: 16307148
• Product Code: MAF
• UDI-Device Identifier: 08717648176470
• UDI-Public: 08717648176470
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/02/2020

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: 06/30/2020
• Device Model Number: 1012583-16
• Device Catalogue Number: 1012583-16
• Device Lot Number: 8073141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/02/2020
• 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: 85 YR
• Patient Weight: 77