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	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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.Based on the similar incident review, there is no indication of a lot specific product quality issue.The investigation determined the reported failure to advance appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the device interacted with the calcium in the anatomy during advancement resulting in the reported failure to advance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
The patient presented with a free perforation in the 1st diagonal.A 2.5x12mm unspecified balloon stent was deployed and subsequent angiogram revealed a perforation near the distal stent edge.The unspecified stent balloon was advanced back into the vessel and inflated.Angiogram was performed with balloon inflated and no additional dye extravasation was present.The balloon was left inflated when a 2.80x26mm rx graftmaster was attempted to be advanced; however, failed to cross through the proximal calcium in the left anterior descending artery.Another prolonged inflation was performed and there was no further dye extravasation therefore, perforation was sealed.Patient had stable blood flow and transthoracic echocardiogram (tte) was negative for pericardial effusion.No further attempt was made to rewire as the physician did not want to reopen the perforation.Patient had no chest pain and was monitored overnight.There were no adverse patient sequela and no clinically significant delay.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: 11599831
• Report Number: 2024168-2021-02588
• Device Sequence Number: 4150631
• Product Code: MAF
• UDI-Device Identifier: 08717648176364
• UDI-Public: 08717648176364
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/31/2021

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: 05/31/2021
• Device Model Number: 1012580-26
• Device Catalogue Number: 1012580-26
• Device Lot Number: 9060441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/31/2021
• 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: 88 YR
• Patient Weight: 87