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

Model Number	1804300-33
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that during the procedure the stent from the 3.0x33mm xience skypoint stent delivery system (sds) dislodged.The stent was retrieved.There was no adverse patient sequela reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product were not performed because the lot number was not reported and the product was not returned for analysis.The investigation determined the reported difficulties and treatment appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9: information updated - device has reportedly been discarded.
Event or Problem Description
It was reported that during the procedure the stent from the 3.0x33mm xience skypoint stent delivery system (sds) dislodged.The stent was retrieved.There was no adverse patient sequela reported and no clinically significant delay reported.Subsequently after the initial was filed, the account confirmed during removal of the xience skypoint resistance was noted with an unspecified telescope guide extension and the stent dislodged.The stent was retrieved via snare with a balloon.Another non-abbott stent was used to successfully complete the procedure.It was noted that there was clinically significant delay.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: 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: 14187933
• Report Number: 2024168-2022-04362
• Device Sequence Number: 4408250
• Product Code: NIQ
• UDI-Device Identifier: 08717648233272
• UDI-Public: 08717648233272
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1804300-33
• Device Catalogue Number: 1804300-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown