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

Catalog Number 1800350-48

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2024

Event Type  Injury  

Event Description

It was reported that the hi-torque balance heavyweight hydro guide wire broke in two, in the stent.The 3.5x48mm xience skypoint stent separated and a stent fracture was noted at the ostium of the right coronary artery.Another stent was use to embed the separated portion of the stent; however, it is unknown if the separated portion of the guide wire was removed.There was no clinically significant delay reported.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 hi-torque balance heavyweight device referenced in b5 is filed under separate medwatch report number.

Manufacturer Narrative

The device was not returned for evaluation.The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported material separation could not be determined; however the subsequent device embedded in vessel or plaque and unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to the operational context of the procedure.Factors contributing to a material separation include, but are not limited to, damage during manufacturing, interaction with accessory devices or inadvertent mishandling.In this case, it is possible that the stent fractured due to interaction with accessory devices (guide wire), ultimately causing the reported material separation (stent); however, without the device to examine, this cannot be confirmed.Another stent was used to embed the separated portion of the stent into the anatomy.It is unknown if the separated portion of the guide wire was removed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequently, it was noted that no piece of the guide wire left in the anatomy and per device return it was noted that the entire length of the guide wire was returned; however, separated from the distal core and shaping ribbon from the solder tip.There was no adverse patient effects reported.No additional information was provided.

• 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: 18862435
• MDR Text Key: 337180188
• Report Number: 2024168-2024-02982
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648230264
• UDI-Public: (01)08717648230264(17)260817(10)3082341
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800350-48
• Device Lot Number: 3082341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2023
• 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: HI-TORQUE BALANCE HEAVYWEIGHT HYDRO GUIDE WIRE
• Patient Outcome(s): Required Intervention