MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804350-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Ischemia (1942); Nausea (1970); Ventricular Fibrillation (2130); Respiratory Failure (2484); Thrombosis/Thrombus (4440)
Date of Event	10/17/2024
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 device referenced in b5 is captured under a separate medwatch number.
Event or Problem Description
It was reported that the procedure was to treat the left main (lm) and left circumflex (lcx) coronary arteries.The left anterior descending (lad) coronary artery was accessed with a blance middleweight universal guide wire and pre-dilated with 2.5x12 mm compliant balloon, 3.0x15 mm nc balloon and a 3.0x15 mm non-abbott balloon.Underexpansion was noted so a 3.5x12 mm non-abbott balloon was used for intravascular lithotripsy.Again the lesion was pre-dilated with a 3.5x12 mm nc balloon and the 3.5x28 mm xience skypoint stent was deployed in the left main.Post-dilatation was performed with 3.5x12 mm and 4.5x12 mm nc balloons.Next the lcx was accessed with a non-abbott wire and a 3.0x15 mm nc balloon was used to pre-dilate the lesion and after initial kissing balloon technique, the 3.0x18 mm xience skypoint stent was implanted from the left main into the lcx, layered with the previously implanted 3.5x28 mm xience skypoint stent.The proximal optimization technique (pot) was performed with a 4.5x8 mm nc balloon and kissing balloon was performed with 3.5x12 mm nc in the lad and 3.0x12 mm nc in the lcx.At this point the activated clotting time (act) came back subtherapeutic and additional heparin was given.Repeat act after several minutes was even lower.All guide wires were removed and a final angiogram was performed which showed a filling defect in the lm consistent with possible thrombus.Aggrastat bolus and drip and intra-arterial heparin were given.Patient was nauseous and hypotensive with st changes.A large thrombus was seen in the lm and the guide wire was attempted to be placed to remove the thrombus however the patient became more hypotensive and went into cardiac arrest.Cardiopulmonary resuscitation (cpr) was started and the patient was shocked multiple times for episodes of ventricular fibrillation.During chest compressions an impella pump was placed and a bmw guide wire was placed in the lad for angioplasty and multiple rounds of aspiration thrombectomy were performed with a penumbra catheter but intravascular ultrasound (ivus) showed layered thrombus in the lm.Angioplasty was performed with a 4.0x12 mm compliant balloon and a thrombectomy catheter was used and the patient was given tissue plasminogen activator (tpa).The patient went into cardiac arrest again and again balloon angioplasty was performed.The patient was monitored on the table for 1 1/2 to 2 hours.The patient required many medications but they continued to decline.Cpr was stopped and the patient became hypoxic, with fluoroscopy showing possible pulmonary edema and there was significant bleeding from the tube.Aggrastat was stopped and the patient transferred to the cardiac care unit and care was de-escalated.The patient expired due to myocardial ischemia and stent thrombosis.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The reported patient effects of thrombosis, nausea, hypotension, ventricular fibrillation, and ischemia are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears 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; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20738501
• Report Number: 2024168-2024-13778
• Device Sequence Number: 8648599
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: (01)08717648233425(17)260709(10)3071741
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/17/2025

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: 07/09/2026
• Device Model Number: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 3071741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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: 3.0X18 MM XIENCE SKYPOINT STENT.; 3.0X18 MM XIENCE SKYPOINT STENT.; ASAHI PROWATER GUIDE WIRE.; ASAHI PROWATER GUIDE WIRE.; BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE (3).; BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE (3).; GUIDELINER.; GUIDELINER.; MEDTRONIC LAUNCHER.; MEDTRONIC LAUNCHER.; PENUMBRA CATHETER.; PENUMBRA.; RUNTHROUGH GUIDE WIRE.; RUNTHROUGH GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 149 KG
• Patient Race: White