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

Model Number	1804400-38
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Material Rupture (1546); Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified left main coronary artery (lm) and proximal left anterior descending artery.The 4.0x38mm xience skypoint stent delivery system (sds) was noted to rupture at 5 atmospheres; however, the stent was deployed dog bone shaped.The sds was deflated, removed with resistance met with the stent and the stent moved to the proximal part of the lesion.Post-dilatation was performed to deploy the stent completely.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported device dislodged or dislocated and leak/splash was confirmed.The reported material rupture and difficult or delayed activation could not be confirmed.The reported difficult to remove could not be tested due to the device condition.The reported migration could not be tested as it was based on operational context.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 other incidents/complaints from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.In this case, analysis of the returned device discovered a leak at the torn guidewire exit notch.It is likely that manipulation of the stent delivery system (sds) during the procedure resulted in the guide wire exit notch damage and subsequently contributed to the reported leak and stent dislodgement.Additionally, it is likely that the sds interacted with the partially deployed stent during removal, as resistance was noted, resulting in the reported difficult to remove sds and stent migration.Although the reported balloon rupture and difficult balloon expansion were unable to be confirmed by return analysis, it is possible that the noted leak is what contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified left main coronary artery (lm) and proximal left anterior descending artery.The 4.0x38mm xience skypoint stent delivery system (sds) was noted to rupture at 5 atmospheres; however, the stent was deployed dog bone shaped.The sds was deflated, removed with resistance met with the stent and the stent moved to the proximal part of the lesion.Post-dilatation was performed to deploy the stent completely.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.Subsequently, after initial report was filed.The account confirmed the stent of the xience skypoint did dislodge as well a leak was noted between the shaft and the balloon.No additional information was provided.

• 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: 15987570
• Report Number: 2024168-2022-12669
• Device Sequence Number: 6151336
• Product Code: NIQ
• UDI-Device Identifier: 08717648233524
• UDI-Public: 08717648233524
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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 Expiration Date: 06/29/2024
• Device Model Number: 1804400-38
• Device Catalogue Number: 1804400-38
• Device Lot Number: 1062442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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