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

Model Number	1012581-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Obstruction/Occlusion (2422)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional xience skypoint device referenced is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery.Pre-dilatation was performed using a 3.0x20mm trek balloon at 8 atmospheres (atms) for 20 seconds.Next, a 3.5x28mm xience skypoint stent was deployed in the proximal to mid lad at 14 atms for 30 seconds, however, the distal third of the stent appeared slightly under-expanded related to calcific disease.A 4.0x20mm non-compliant trek balloon was used for post dilatation of the distal third of the xience skypoint stent at 12 atms for 20 seconds and the proximal portion at 16 atms for 20 seconds.The patient then had a pulseless electrical activity cardiac arrest with a sudden drop in blood pressure.Patient became unconscious.Angiography showed a large free-flowing perforation extending from the distal third of the stent into the pericardium.Cardiopulmonary resuscitation (cpr) was started and doses of intravenous epinephrine was given.A stat echocardiogram showed anterior pericardial effusion.Immediately after recognizing the perforation, the 4.0x20mm trek balloon was re-inflated at 12 atms and angiography showed adequate control of the pericardial effusion.After leaving the balloon up for at least 15 minutes, the balloon was deflated and angiography showed continued large free flowing pericardial effusion.The perforation still did not seal with the prolonged balloon inflation and the trek balloon was removed rapidly.The 3.5x19mm grafmaster covered stent was deployed within the stented segment at 16 atms for 60 seconds.Angiography showed no further extravasation from the coronary perforation location, however, there was a large disruption of the distal lad which appeared to be a possible complex dissection or localized perforation.A very distal septal branch was occluded by the covered stent.Pericardiocentesis was performed when a pericardial drain was placed on first attempt.After prolonged effort on maximum doses of intravenous dopamine and epinephrine, resuscitative efforts were ceased.The patient had progressive hypotension with pulseless electrical activity and died in the cardiac cath lab.No additional information was provided.
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.The reported patient effects of perforation, occlusion and hypotension are listed in the graftmaster rx coronary stent graft system, instructions for use, as known patient effects that may be associated with use of a coronary stent in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the reported 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.

• 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: 16762422
• Report Number: 2024168-2023-03945
• Device Sequence Number: 16909621
• Product Code: MAF
• UDI-Device Identifier: 08717648176401
• UDI-Public: 08717648176401
• 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: 2023
• 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): 05/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 1012581-19
• Device Catalogue Number: 1012581-19
• Device Lot Number: 2032341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X28MM XIENCE SKYPOINT STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 42 KG