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

Model Number	1012583-19
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
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 device 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.Additional information has been requested.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additional information was received reporting that the 4.5x19mm rx graftmaster stent sealed the perforation successfully and there were no issues with the use of the device therefore, no investigation is required.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.Codes 4641, 2682 were removed.
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.

• 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: 12700159
• Report Number: 2024168-2021-09616
• Device Sequence Number: 1364386
• Product Code: MAF
• UDI-Device Identifier: 08717648176487
• UDI-Public: 08717648176487
• 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): 11/08/2021

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: 12/31/2022
• Device Model Number: 1012583-19
• Device Catalogue Number: 1012583-19
• Device Lot Number: 1012741
• 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: 11/01/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GRAFTMASTER US RX 4.00X19
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 168 KG