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

Model Number	1012581-26
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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 did not indicate a lot specific quality issue.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the left main coronary artery.The 3.5x26 mm graftmaster covered stent was attempted to be advanced to treat the perforation but failed to cross the lesion due to the anatomy.The graftmaster covered stent was readvanced with a non-abbott guide support catheter but could not be advanced through the guide support catheter so the graftmaster was removed from the anatomy.A non-abbott balloon was used and the patient became hypotensive.An echocardiogram showed no evidence of pericardial effusion or cardiac tamponade.Additional dilatation was performed and a non-abbott covered stent was used to seal the perforation.There was no reported adverse patient sequela and no reported clinically significant delay in the procedure as a result of the failure to cross.The patient recovered well.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: 12453590
• Report Number: 2024168-2021-08069
• Device Sequence Number: 3936062
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/10/2021

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: 07/31/2022
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 0083141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/10/2021
• 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: 69 YR
• Patient Weight: 98