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

Catalog Number UNK XIENCE SKYPOINT

Device Problems Difficult to Remove (1528); Defective Device (2588); Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915); Difficult to Advance (2920); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi is unknown as the part/lot number were not provided.

Event Description

It was reported that the procedure was to treat the distal right coronary artery (rca) with no tortuosity or calcification.The target lesion was an st elevated myocardial infarction (stemi) culprit lesion.The xience skypoint stent was implanted and after deployment, the intervention guide wire was pulled back accidently which required the lesion to be re-wired across the stent.The guidewire caught on the proximal stent edge and the stent moved as the physician was trying to pull the guide wire back but the stent remains fully in the target lesion.The stent was able to be re-crossed and was post-dilated successfully per standard practice.There were no reported adverse patient effects.There was a delay in the procedure but no harm to the patient.No additional information was provided.

Event Description

It was reported that the procedure was to treat the distal right coronary artery (rca) with no tortuosity or calcification.The target lesion was an st elevated myocardial infarction (stemi) culprit lesion.The xience skypoint stent was implanted and after deployment, the intervention guidewire was pulled back accidently which required the lesion to be re-wired across the stent.The guidewire caught on the proximal stent edge and the stent moved as the physician was trying to pull the guide wire back but the stent remains fully in the target lesion.The stent was able to be re-crossed and was post-dilated successfully per standard practice.There were no reported adverse patient effects.There was a delay in the procedure but no harm to the patient.Subsequent to the initially filed report, the following information was provided: the stent was under-expanded and undersized.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The investigation determined the reported difficulties 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.B1 - adverse event/product problem: adverse event added.H1 - type of reportable event updated to serious injury.H6 - removed medical device problem code 2920.

• 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: 14046103
• MDR Text Key: 288998970
• Report Number: 2024168-2022-03703
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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: 04/19/2022
• 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
• Patient Outcome(s): Required Intervention