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

Catalog Number 1804250-18

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a 90% stenosed, mildly calcified and moderately tortuous lesion in the proximal left circumflex artery (plcx).The 2.5x18mm xience skypoint stent delivery system (sds) balloon was inflated, however, the balloon ruptured during the first inflation at 8 atmospheres.The sds was mostly contained within the guiding catheter; therefore, was removed with the guiding catheter.Another xience skypoint was used to continue the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.

Event Description

Return device analysis noted the hypotube was separated.Follow up with the account confirmed that the separation was not noted during the procedure.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported material rupture was not confirmed; however, a material separation [of the shaft] was observed.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.A conclusive cause for the reported material rupture and observed material separation could not be determined; however, factors that may contribute to material ruptures include, but are not limited to, material damage, inflation technique, interaction with accessory devices, lesion calcification and tortuosity or insufficient preparation prior to use.Potential causes for a material separation include, but are not limited to, damage during manufacturing, inadvertent mishandling during unpackaging, during preparation or use of the device, interaction with the anatomy and/or accessory devices.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue did not contribute to the reported material rupture.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: 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: 18256800
• MDR Text Key: 329610384
• Report Number: 2024168-2023-13384
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804250-18
• Device Lot Number: 3041441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F GUIDING CATHETER.