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

Model Number	1012582-26
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/10/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The stent remained implanted and is not returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2020, an atherectomy was performed in the left anterior descending (lad) coronary artery when a perforation occurred.Balloon angioplasty was performed and drug-eluting stents were successfully implanted.The perforation continued and as additional treatment, a non-abbott covered stent was implanted.The perforation continued and a 4.0x26mm graftmaster stent (1012582-26, 9071641) was successfully implanted.The perforation however, had not sealed.There was no device malfunction noted, however, the cause of continued bleeding/perforation was unknown.Reportedly, it is unknown if there was any device leaking.The patient was taken to surgery and open heart surgical repair was performed.The bleeding had continued and a pericardiocentesis was performed.On (b)(6) 2020, the patient expired due to complications from the perforation.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 did not indicate a lot specific quality issue.It should be noted that the reported patient effects of surgical procedure and death, as listed in the graftmaster rx coronary stent graft system, instructions for use, are known patient effects that may be associated with use of a coronary stent in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.H6: patient code 1888 removed.
Event or Problem Description
Subsequent to the previous medwatch report, the additional information was received via abbott vascular review of cine.An impella device was placed for the coronary intervention.An atherectomy was performed in the left anterior descending (lad) coronary artery when a perforation occurred.Drug eluting stents were placed, however, the bleeding continued and started to bleed into the pericardium.Pericardiocentesis was performed and another des was implanted in the proximal lad.The bleeding continued.The lcx was also jailed by the unspecified des implanted in the lad.Further imaging was performed and the perforation could have been a spiral dissection of the lad.The non-abbott covered stent (papyrus) was then implanted.Imaging was performed and the 4.0x26mm graftmaster stent (1012582-26, 9071641) was implanted.Balloon angioplasty was performed several times, including in the lad and cx as well as kissing balloon attempts in the lad and cx ostium.Cardiopulmonary resuscitation (cpr) and then open heart surgery were performed with possible ecmo cannulation.Pericardial pacing wires, surgically placed grafts within the chest wall, and a swan-ganz catheter was placed.On (b)(6)2020, the patient had expired due to complications from the perforation.

• 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: 10233624
• Report Number: 2024168-2020-05478
• Device Sequence Number: 594842
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 06/30/2021
• Device Model Number: 1012582-26
• Device Catalogue Number: 1012582-26
• Device Lot Number: 9071641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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: IMPELLA; PAPYRUS COVERED STENT; PAPYRUS COVERED STENT
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Weight: 66