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

Model Number	1804325-12
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation.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 performed to treat a de novo lesion in the moderately calcified, moderately tortuous, 75% stenosed proximal left anterior descending coronary artery.A 3.25x12mm xience skypoint stent delivery system (sds) was advanced, and the balloon was inflated three times at 12 atmospheres.However, the balloon could only partially deflate after stent implantation.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported deflation problem was not confirmed.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 was reported that the xience skypoint stent delivery system (sds) was prepped with 100% contrast.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: prepare an inflation device/syringe with diluted contrast medium.The material required lists contrast diluted 1:1 with heparinized normal saline.In this case, it appears the instruction for use (ifu) deviation related to incorrect contrast dilution may have contributed to the reported event.The investigation determined the reported deflation issue appears to be related to the user error as 100% contrast was used to prepare the device.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 performed to treat a de novo lesion in the moderately calcified, moderately tortuous, 75% stenosed proximal left anterior descending coronary artery.A 3.25x12mm xience skypoint stent delivery system (sds) was advanced, and the balloon was inflated three times at 12 atmospheres.However, the balloon could only partially deflate after stent implantation.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the contrast mix was 100% as opposed to a 50/50 mix.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: 12533014
• Report Number: 2024168-2021-08614
• Device Sequence Number: 16429111
• Product Code: NIQ
• UDI-Device Identifier: 08717648233302
• UDI-Public: 08717648233302
• 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: 2021
• 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): 10/21/2021

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: 1804325-12
• Device Catalogue Number: 1804325-12
• Device Lot Number: 0082641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1