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

Model Number	1012581-19
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation occurred during an intervention to the left anterior descending (lad) coronary artery.A 3.5x19mm graftmaster covered stent was advanced and implanted, but failed to seal the perforation.Next a 4x19mm graftmaster covered stent was implanted, but the perforation remained unsealed.It is unknown if the perforation was ever sealed; however, sometime after the full intervention, the patient experienced pulseless electrical activity (pea arrest) and could not be resuscitated.The patient died.Per the physician, the graftmaster stents did not cause or contribute to complications or adverse events.There was no additional information provided.
Additional Manufacturer Narrative
The stent remains implanted.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 4.00x19mm graftmaster stent is filed under a separate medwatch report number.
Event or Problem Description
Subsequent to the initial filed reports, the following information was received: it was reported that the patient sustained a pulseless electrical activity arrest (pea) with acute closure of the left main (lm) and left anterior descending (lad) artery after the placement of unspecified stents.The patient was receiving active cardiopulmonary resuscitation (cpr) throughout the following hour which limited the ability to image the vessel and treat the patient.The guiding catheter (gc) was in the left main (lm) with a guide wire (gw) in the lad when the patient went into cardiac arrest.The image intensifier (cath lab camera) had to be move out to allow staff to perform cpr.The camera was only able to be repositioned for short sequences to try to stabilize the patient.When the camera was moved back into position for a few seconds, the guiding catheter and wire appeared to be in the same position but had unknowingly dropped out of the artery and the wire prolapsed into the left ventricle (lv).Contrast injections demonstrated extravasation of contrast in the cusp near the valve leading to conclude that there was a left main perforation.The guide wire was coursing under the anterior surface of the lv directly below and along the same course of the epicardial lad, leading to the conclusion the gw was in the lad when it was not.The 3.5x19mm graftmaster covered stent was placed over the wire with the belief it was in the left main and deployed.More camera removal and cpr followed.When reimaging was done, the graftmaster could not be located and a 4x19mm graftmaster was deployed.Ultrasound demonstrated no pericardial effusion leading us to perform longer imaging runs that allowed us to identify that the graftmaster stents had migrated along the wire and were in the lv.The gc was eventually repositioned during cpr cycles, the artery was eventually re-cannulated and successfully stented gaining reperfusion.All this was done in short segments of time as he received cpr for approximately one hour without recovery of spontaneous circulation (rosc).No meaningful sustained rhythm was ever achieved, and the patient was pronounced dead in the cath lab.Had the patient survived, the graftmaster stents would have been retrieved from the lv percutaneously.It is the physician¿s opinion that the graftmaster stents did not ¿seal the perforation¿ as it was eventually determined there was no perforation and the guide wire was dislodged by cpr into the lv.The use of graftmaster stents did not help nor hurt the patient in any way and had no effect on the patient outcome.
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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the foreign body in patient appears to be related to the operational context of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.B1 - adverse event/product problem: product problem - removed.B2 - outcomes attributed to ae required intervention - removed.D6a.Implant date - stent was not implanted.H6: health effect - clinical code 4582 -removed.H6: health effect - impact code 4641 - removed.H6: medical device problem code 2682 - removed.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15021866
• Report Number: 2024168-2022-07727
• Device Sequence Number: 6856050
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: 08717648176401
• 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
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 10/31/2022
• Device Model Number: 1012581-19
• Device Catalogue Number: 1012581-19
• Device Lot Number: 0112741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male