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

Catalog Number	1804400-18
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.E1 - facility name: (b)(6) hospital.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in an unspecified lesion.A shockwave was used for the calcified lesion.After the device upsized, a high-pressure balloon dilatation catheter was used for post-dilatation, and a xience skypoint des 4.00 x 18 rx skypoint stent was deployed.However, indentation was slightly remained, but the user judged lumen was dilated enough; the balloon was not inflated well due to the stiff (calcified) lesion.The procedure was completed without issue, though.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.The electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported inflation problem.Factors that may contribute to an inflation problem include, but are not limited to, inflation technique, anatomical conditions, contrast concentration, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is possible that the device may have interacted with the moderately calcified, 70% stenosed lesion during deployment, as it was reported that the balloon did not inflate well due to the stiff lesion, causing the reported inflation problem; however, without the device to examine, a definitive cause cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B5 - describe event or problem: updated e1 - facility name: (b)(6) hospital.
Event or Problem Description
Subsequent to the previously filed report, additional information was received.The lesion was located in the mid left anterior descending coronary artery that was moderately calcifed, non-tortuous and 70% stenosed.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: 19051966
• Report Number: 2024168-2024-04341
• Device Sequence Number: 7339036
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: (01)08717648233487(17)240621(10)1061642
• 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: 2024
• 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): 05/03/2024

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: 06/21/2024
• Device Catalogue Number: 1804400-18
• Device Lot Number: 1061642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2021
• 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
• Patient Sex: Unknown