MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE SKYPOINT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Coma (2417); Pericardial Effusion (3271)

Event Date 03/27/2023

Event Type  Death  

Event 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.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional graftmaster device referenced in b5 is filed under separate medwatch report number.The udi number is not known as the part and lot number were not provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of hypotension, perforation, pericardial effusion and death are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A medical review was performed by an abbott vascular clinical specialist.The reviewer concluded the following: a medical review was performed by an abbott vascular clinical specialist.The reviewer concluded the following: this is a case of an 82 year old female with multiple co-morbidities who came in for a percutaneous intervention of the lad.A 3.5x28mm xience skypoint stent was deployed in the proximal to mid lad, however, the distal third of the stent appeared slightly under-expanded related to calcific disease.Nc trek balloon was used for post dilatation of the distal third of the xience skypoint stent when patient went into cardiac arrest.Based on the limited information provided the main cause of death was most likely due to cardiogenic shock and cardiac tamponade secondary to a large coronary artery perforation.Patient had multiple disease burden in addition to a calcific lesion that probably caused the distal third of the stent to be slightly under-expanded.To treat the under-expansion, nc trek balloon was used for post dilatation of the distal third which could have contributed to the large perforation.Hence, xience skypoint indirectly contributed to the outcome of death due to the under-expansion but procedural complications including the calcific lesions, the post-dilatation of the distal-third and patient¿s disease burden have all contributed to patient¿s demise.The investigation determined the reported patient-device incompatibility (recoil) and treatment appear to be related to operational circumstances of the procedure as it is likely the stent interacted with the patients multiple disease burdens in addition to a calcific lesion causing the distal third of the stent to be slightly under expanded.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: DRUG ELUTING 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: 16762242
• MDR Text Key: 313508655
• Report Number: 2024168-2023-03941
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE SKYPOINT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4.0X20MM NON-COMPLIANT TREK BALLOON.
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 42 KG