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

Catalog Number	1804300-12
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	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 did not indicate a lot specific quality issue.It should be noted that the xience skypoint everolimus eluting coronary stent system instructions for use (ifu) 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 deviation of the ifu does not appear to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily tortuous and heavily calcified anatomy resulting in the reported failure to advance and the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience skypoint is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily tortuous and heavily calcified concentric lesion in the right coronary artery.Following pre-dilatation, a 3.0x12mm xience skypoint stent delivery system (sds) was advanced, but failed to cross due to resistance with the anatomy.Several attempts were made to cross, but were unsuccessful.During removal of the sds resistance with the anatomy was felt.An unspecified drug-coated balloon catheter was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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
• MDR Report Key: 11780786
• Report Number: 2024168-2021-03837
• Device Sequence Number: 11706681
• Product Code: NIQ
• UDI-Device Identifier: 08717648233227
• UDI-Public: 08717648233227
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 09/29/2023
• Device Catalogue Number: 1804300-12
• Device Lot Number: 0092241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1