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

Model Number	1012581-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents from this lot.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 the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a perforation in the proximal left anterior descending coronary artery.The patient presented with a non-st elevated myocardial infarction.An unspecified 6f sheath and non-abbott guide catheter were used with a non-abbott guide wire and a non-abbott atherectomy catheter.Unspecified 2.5x12mm and 3x12mm nc balloons were used for pre-dilatation, and a 2.5x38mm non-abbott stent was used but failed to cross.After further dilatation using the 3x12 nc balloon, a perforation was noted, so the same balloon was used as treatment.The patient became hypotensive and bradycardic, so pericardiocentesis was performed.The graftmaster was quickly prepped and inserted.It was during the failure to cross attempts that they realized the perforation was already sealed from the previous balloon treatment.The graftmaster was removed without issue.The patient was then sent to surgery as thrombus, unrelated to the graftmaster, was noted but with good flow, and there were other procedural complications.An unspecified intra-aortic balloon pump was used with an 8f sheath.In the opinion of the physician, the use of this graftmaster did not cause or contribute to complications or adverse events in any way.There were no adverse patient sequelae and no clinically significant delay in the procedure.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: 10868909
• Report Number: 2024168-2020-09734
• Device Sequence Number: 16965323
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 9032941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F SHEATH; CLS 3.5 GUIDE CATHETER; VIPER GUIDE WIRE
• Patient Age: 83 YR