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

Model Number	1012581-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/14/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional graftmaster devices are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that atherectomy was performed and caused a free perforation with extravasation in the heavily calcified right coronary artery.A 2.8x26mm graftmaster rx covered stent system (css) failed to cross due to the anatomy and the shaft kinked and separated.The separated shaft was simply withdrawn.A 2.8x16mm, 4.0x19mm, and 3.5x26mm graftmaster rx css also failed to cross due to the anatomy.A 3.5x16mm graftmaster rx css was advanced and the stent was deployed at 12 atmospheres; however, the perforation was not sealed.The patient experienced a cardiac tamponade, which was treated with pericardiocentesis; however, the patient expired.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported failure to advance could not be tested as it was based on operational circumstances.The reported patient effect of death listed in the graftmaster rapid exchange coronary stent graft system, domestic instructions for use as a known patient effect of coronary stenting procedures.Abbott vascular medical affairs reviewed the reported information and a clinical review was performed.The conclusion was that death in this case is a result of the perforation.Delay caused by the inability to reach and exclude the perforation may have secondarily contributed to the patient¿s death.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 and subsequent treatment appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9433132
• Report Number: 2024168-2019-14253
• Device Sequence Number: 14076259
• 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,Followup
• Report Date (Section B): 01/30/2020

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: 02/29/2020
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 8031641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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: Death
• Patient Age: 84 YR