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

Catalog Number 1804225-23

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the first diagonal branch artery lesion.A 2.25x23 xience skypoint stent delivery system (sds) was attempted to be placed via radial approach but was unsuccessful.During removal the sds got caught on a previous implanted stent and the stent was stripped off the delivery system.There was an attempt to snare the device out but was unsuccessful.A semi complaint 1.5x15mm balloon was used to pull the stent back to the proximal artery and the stent was crushed against the artery wall.A 3.0x23mm xience skypoint was then deployed across it.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported failure to advance.The reported difficulty to remove, stent dislodgement and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 18846106
• MDR Text Key: 336996823
• Report Number: 2024168-2024-02786
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233012
• UDI-Public: 08717648233012
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804225-23
• Device Lot Number: 106214A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: 1.5X15MM SEMI COMPLAINT BALLOON.; 3.0X23MM XIENCE SKYPOINT.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 98 KG