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

Model Number	1012581-26
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was discarded and will not be returned.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 2.8x19mm and 4.0x19mm graftmaster devices referenced are filed under a separate medwatch report numbers.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient presented with a proper hepatic artery bleeding pseudoaneurysm with hematobilia and a transplanted liver.An arterial thrombosis from the common hepatic artery for persistent thrombus within the proper hepatic arterial unspecified stent, throughout the distal proper hepatic artery, and persistent occlusion of the right hepatic artery.Coil embolization was performed within the gastroduodenal artery (gda) and microcatheter advanced.A 2.8x19mm graftmaster (gm) stent (1012580-19, 8051141--expired) was implanted.No further extravasation was observed.Post-procedure imaging was performed and the 2.8x19mm gm stent had occluded with thrombus.It is unknown if this thrombus was per-existing.Medication were provided and another catheterization was performed that same day to infuse percutaneous thrombolytics overnight.On (b)(6) 2020, the patient presented with proper hepatic artery hemorrhage from the same site, unknown if the 2.8x19mm gm stent had failed to seal.The right hepatic artery stenosis was treated with balloon angioplasty and angioplasty was performed throughout the occluded gm stent.A 3.5x26mm graftmaster (1012581-26, 8031641-expired) advanced, however, had difficulty advancing/tracking over the unspecified guidewire.The device was removed without issue.Once out of the anatomy, the stent appeared ¿rough and sharp¿.Another device was used in replacement.In replacement, the 3.5x19mm graftmaster stent (1012581-19, 9032941¿not expired) and 4.0x19mm graftmaster (1012582-19, 8051041-expired) stents were properly implanted, sealing the areas of extravasation.Both stents were needed to seal the perforation due to the perforation size.There was no stent leaking and no device issue with either the 3.5x19mm or the 4.0x19mm gm stents.There was no device malfunction and no complaint regarding these two devices.Post procedure imaging displayed optimal results.Hemostasis had been achieved with no further extravasation noted.There was no adverse patient sequela reported.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use, (ifu) states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.It was reported that the graftmaster was used past the expiration date.The expiration date of the product is important for sterility, efficacy, and performance of the device.It should be noted that the graftmaster rapid exchange rx coronary stent graft system ifu states: note the product use by date specified on the package.The investigation was unable to determine a conclusive cause for the reported material deformation and difficult to advance over the guidewire.The reported device expiration issue appears to be related to the use error.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 10255758
• Report Number: 2024168-2020-05650
• Device Sequence Number: 3484621
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/10/2020

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?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: 2.8X19MM GRAFTMASTER STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 72