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

Catalog Number 1804225-28

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

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

Event Date 12/21/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the proximal to mid circumflex coronary artery with heavy calcification.A dissection was noted.The 3.0x28 mm xience skypoint stent delivery system (sds) failed to cross the lesion and was not long enough for the dissection, therefore the sds was removed and replaced with a 33 mm stent.The 2.25x28 mm xience skypoint sds was then attempted to be advanced but the physician did not want to cross the bifurcation due to the dissection.Upon removal from the anatomy, a proximal stent strut became stuck and the stent dislodged from the delivery system.A guidewire was attempted to be used to remove the stent but this was unsuccessful.The stent remains in the anatomy within the target lesion.The dissection was ultimately not treated but seemed to have resolved by the end of the procedure.No additional information was provided.

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 the proximal to mid circumflex coronary artery with heavy calcification.A dissection was noted.The 3.0x28 mm xience skypoint stent delivery system (sds) failed to cross the lesion and was not long enough for the dissection, therefore the sds was removed and replaced with a 33 mm stent.The 2.25x28 mm xience skypoint sds was then advanced and was intended to treat the dissection but the physician did not want to cross the bifurcation due to the dissection.Upon attempted removal from the anatomy, a proximal stent strut became stuck and the stent dislodged from the delivery system.A guidewire was attempted to be used to remove the stent but this was unsuccessful.The stent remains in the anatomy within the target lesion.The dissection was ultimately not treated but seemed to have resolved by the end of the procedure.Subsequent to the initially filed report, it was reported that after the 3.0x28 mm xience skypoint sds failed to cross the lesion, a 33 mm xience stent was implanted.Next, the 2.25x28 mm xience skypoint sds reached the lesion but was removed as it was deemed a longer stent was needed.There was no resistance during advancement.The 2.25x28 mm xience skypoint sds caught on a proximal strut of a previously implanted xience 33 mm stent.There was no damage noted to the 33 mm xience stent.No additional information was provided.

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.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 - medical device problem code 2524 was removed.

Manufacturer Narrative

Nasubsequent to filing the final report, it was determined that the medwatch received and attached to the previous report was not associated with this complaint; therefore, the medwatch is being removed.

• 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: 18504532
• MDR Text Key: 332794064
• Report Number: 2024168-2024-00720
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233029
• UDI-Public: 08717648233029
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804225-28
• Device Lot Number: 2121541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 92 KG