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

Model Number	1804275-23
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.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 heavily tortuous, moderately calcified distal circumflex.The 2.75x23mm xience skypoint stent delivery system (sds) was attempted to be advanced; however, failed to cross due to anatomy.The sds was taken out and re-inserted with an extension catheter, but the sds still failed to cross.During removal of the sds resistance was met with anatomy.An unspecified dilatation catheter balloon was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional 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.It should be noted, that the xience skypoint everolimus eluting coronary stent system instruction for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery, once it has been pulled back into the guiding catheter.Subsequent, movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged, during retraction back into the guiding catheter.The investigation determined, the reported difficulties appear to be related to circumstances of the procedure.As it is likely, the device met resistance with the heavily tortuous and moderately calcified anatomy, causing the reported failure to advance.The device was removed.And a new guiding catheter was added.And the device was advanced once again (against instructions for use).The device once again met resistance with the anatomy and could not advance.During removal, the device met resistance with the anatomy causing the reported difficulty to remove.There is no indication, of a product quality issue with respect to manufacture, design or labeling.The xience skypoint device is not currently available in the us.However, it is similar to a device sold in the us.

• 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
• MDR Report Key: 11849654
• Report Number: 2024168-2021-04188
• Device Sequence Number: 19781471
• Product Code: NIQ
• UDI-Device Identifier: 08717648233173
• UDI-Public: 08717648233173
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: 1804275-23
• Device Catalogue Number: 1804275-23
• Device Lot Number: 0082041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1