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

Model Number 1804300-28

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problems Angina (1710); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

Event Date 01/05/2022

Event Type  Death  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on (b)(6) 2022, a procedure was performed to treat the bifurcation of the left anterior descending (lad) artery.Three xience skypoint's were deployed without issues.An additional skypoint was attempted to be inserted, but the physician noticed the stent became damage while pushing through the tuohy.Therefore, the stent was removed and a balloon was inserted in an attempt to pass through the most proximal implanted stent.However, the balloon was unable to pass through the stent and after roughly 30 minutes, it was observed the implanted stent had become completely occluded.Clots were then observed at the occluded stent and in the left main.It was noted no clotting occurred near the other two implanted stents.Additional heparin was then administered.Aspiration was performed and the clot was successfully removed.However, the st elevation increased and the patient started to have chest pains.The patient then became unresponsive and chest compressions were performed.The patient was intubated and left the operating room on a ventilator.On (b)(6) 2022, the patient passed away.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 identified no similar incidents from this lot.The investigation determined the reported difficulty to advance/position (crossability) appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined; however, the reported treatments including delay of treatment/therapy appear to be related to the operational context of the procedure.Angina, death, thrombosis, and respiratory failure are listed in the instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2022, a procedure was performed to treat the bifurcation of the left anterior descending (lad) artery.Three xience skypoint's were deployed without issues.An additional skypoint was attempted to be inserted, but the physician noticed the stent became damage while pushing through the tuohy.Therefore, the stent was removed and a balloon was inserted in an attempt to pass through the most proximal implanted stent.However, the balloon was unable to pass through the stent and after roughly 30 minutes, it was observed the implanted stent had become completely occluded.Clots were then observed at the occluded stent and in the left main.It was noted no clotting occurred near the other two implanted stents.Additional heparin was then administered.Aspiration was performed and the clot was successfully removed.However, the st elevation increased and the patient started to have chest pains.The patient then became unresponsive and chest compressions were performed.The patient was intubated and left the operating room on a ventilator.On (b)(6) 2022, the patient passed away.Subsequent to the initially filed report, the following information was received: it was noted the diagonal stent was unable to be passed as well.No additional information was provided.

Manufacturer Narrative

H6: medical device problem code - 2017/distal to stent.The device was not returned for evaluation.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 identified no similar incidents from this lot.It was reported that the xience skypoint was attempted to be placed distally through a previously implanted stent.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obliviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.It is unknown the ifu deviation directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficult to advance.The reported patient effects of angina, death, thrombosis, and respiratory failure are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as 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 reported treatments including delay of treatment/therapy 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.No cine films were available to review, so medical review was conducted with the information reported.Due to the lack of procedural information regarding the morphology of the patients bifurcation, act results during the procedure and steps taken while using the dk crush technique it cannot be definitively stated that the prox-mid lad and d1 skypoint des were deployed correctly per the well documented dk crush technique steps and study data.As such the proximal-mid lad and d1 stents may not have been deployed optimally or crushed enough, potentially leaving too much of the d1 stent within the lad and inhibiting any additional device advancement through the 3.0mm x 28mm skypoint stent and across the ostium of the d1 branch where the 2.5mm x 12mm skypoint stent was placed.It can be definitively stated the acute thrombosis of the 3.0mm x 28mm skypoint stent was an indirect cause of the patient¿s death due to missed procedural steps, procedural errors, the prolonged procedure time.Note: acute thrombosis and occlusion are mentioned in section 8.3 potential adverse events of the xience skypoint ifu1: coronary artery complications which may require additional intervention, including: total occlusion or abrupt closure arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture.Tissue prolapse / plaque shift embolism (air, tissue, plaque, thrombotic material, or device) coronary or stent thrombosis (acute, subacute, late, very late) stenosis or restenosis.H6: investigation conclusions code 50 removed.Investigation conclusions codes 18 and 4315 added.

• 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: 13344453
• MDR Text Key: 284832070
• Report Number: 2024168-2022-00828
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233265
• UDI-Public: 08717648233265
• 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,Followup
• Report Date: 04/27/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 1804300-28
• Device Catalogue Number: 1804300-28
• Device Lot Number: 1032241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/11/2022; 04/19/2022
• Supplement Dates FDA Received: 03/02/2022; 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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: IMPLANTED XIENCE SKYPOINT (X2).
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male