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

Model Number	1012580-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 the reported failure to advance 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.The 2.8 x 16 mm graftmaster system referenced will be filed under a separate medwatch report number.
Event or Problem Description
It was reported that the graftmaster stent delivery system (sds) was used to treat a perforation caused by an unspecified device.The graftmaster sds was advanced into the patient anatomy; however, difficulty was met due to the patient anatomy and the deliverability of the device.The 2.8 x 16 mm graftmaster could not be advanced completely across the perforation.The stent was deployed; however, the perforation was only partially sealed.A second graftmaster sds, a 2.8 x 26 mm, was advanced; however, this device was unable to cross due to the patient anatomy and the deliverability of the device.The device was removed without difficulty.Additional balloon dilatation was performed to seal the perforation.Post procedure, the patient was in stable condition.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
• MDR Report Key: 12178543
• Report Number: 2024168-2021-06127
• Device Sequence Number: 19240425
• Product Code: MAF
• UDI-Device Identifier: 08717648176364
• UDI-Public: 08717648176364
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 1012580-26
• Device Catalogue Number: 1012580-26
• Device Lot Number: 9112641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/15/2021
• 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: Other
• Patient Age: 62 YR
• Patient Weight: 88