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

Model Number 1804350-28

Device Problems Stretched (1601); Material Deformation (2976); Activation Failure (3270)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous left anterior descending artery that is 90% stenosed.The 3.5x28mm xience skypoint stent delivery system was attempted to be deployed; however, stent elongation was observed under fluoroscopy.Another xience stent was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.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 material deformation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: health effect - impact code 2199 removed; medical device problem code 1601 removed; medical device problem code 3270 removed.H6: medical device problem code 2976 added; health effect - impact code 2645 added.

Event Description

Subsequent the previously filed report, additional information was provided that reported that the 3.5x28mm xience skypoint stent delivery system (sds) was noted to be flared during preparation; therefore, not used in the patient.There was no patient involvement and no clinically significant delay 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: 16939726
• MDR Text Key: 315360958
• Report Number: 2024168-2023-05212
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: 08717648233425
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 2120741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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