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

Model Number	1012582-19
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.The additional rx graftmaster referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the patient presented with a free perforation with extravasation in the left main/left anterior descending arteries.A 4.5x19mm and 4x19mm rx graftmaster covered stents were deployed at 16 atmospheres (atm) and 15 atm, but failed to seal the perforation.Type of medical intervention was not specified.There were no reported adverse patient sequelae.No additional information was provided.
Event or Problem Description
It was reported that the patient presented with a free perforation with extravasation in the left main/left anterior descending arteries.A 4.5x19mm and 4x19mm rx graftmaster covered stents were deployed at 16 atmospheres (atm) and 15 atm, but failed to seal the perforation.Type of medical intervention was not specified.There were no reported adverse patient sequelae.Subsequent to the initially filed mdr report, the account confirmed that the 4x19mm rx graftmaster was first implanted but failed to seal the perforation.There were no deployment issues with the stent and it did not exacerbate the perforation.Then a 4.5x19mm rx graftmaster stent was deployed and ultimately sealed the perforation.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 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.D9, h3: device status changed from returning to not returned.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12700076
• Report Number: 2024168-2021-09614
• Device Sequence Number: 1364384
• Product Code: MAF
• UDI-Device Identifier: 08717648176456
• UDI-Public: 08717648176456
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 1012582-19
• Device Catalogue Number: 1012582-19
• Device Lot Number: 9112841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 168 KG