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

Catalog Number 1804350-38

Device Problems Break (1069); Leak/Splash (1354); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2023

Event Type  Injury  

Manufacturer Narrative

H6: medical device problem code 2017- incorrect prep 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 mid left anterior descending (lad) coronary artery with mild calcification, no tortuosity and 80% stenosis.The 3.5x38 mm xience skypoint stent delivery system (sds) was advanced to the lesion.When the tech pulled negative on the device and then tried to inflate the device, contrast began to spray out of a crack in the hub of the device.Negative pressure was pulled again and the sds was attempted to be removed; however, the stent dislodged from the balloon.A 2.0 mm balloon was then advanced and used to try and pull the stent back into the guiding catheter.The stent became caught on the moderate proximal disease in the vessel.The balloon was inflated in the distal part of the stent and since the stent was now partially deployed and there was disease in the proximal vessel, the balloon was used to deploy the stent where it was located and post-dilated with a 4.5 mm balloon to match the intravascular ultrasound (ivus) sizing of the vessel.The stent is located completely outside the target lesion; however, the area is diseased.A new 38 mm stent was implanted distally to the original lesion and was connected to the proximal stent.There were no reported adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgement, hub break and hub leak were confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.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 2017 removed.

Event Description

It was reported that the procedure was to treat the mid left anterior descending (lad) coronary artery with mild calcification, no tortuosity and 80% stenosis.The 3.5x38 mm xience skypoint stent delivery system (sds) was advanced to the lesion.When the tech pulled negative on the device and then tried to inflate the device, contrast began to spray out of a crack in the hub of the device.Negative pressure was pulled again and the sds was attempted to be removed; however, the stent dislodged from the balloon.A 2.0 mm balloon was then advanced and used to try and pull the stent back into the guiding catheter.The stent became caught on the moderate proximal disease in the vessel.The balloon was inflated in the distal part of the stent and since the stent was now partially deployed and there was disease in the proximal vessel, the balloon was used to deploy the stent where it was located and post-dilated with a 4.5 mm balloon to match the intravascular ultrasound (ivus) sizing of the vessel.The stent is located completely outside the target lesion; however, the area is diseased.A new 38 mm stent was implanted distally to the original lesion and was connected to the proximal stent.There were no reported adverse patient sequela.Subsequent to the initially filed report it was reported that the contrast mix was 50/50 and the device was prepped outside the anatomy prior to use.When 2 atmospheres was reached during inflation, that is when the device began leaking at the hub.No additional information was provided.

• 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: 18029867
• MDR Text Key: 326855042
• Report Number: 2024168-2023-11948
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233449
• UDI-Public: 08717648233449
• 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
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804350-38
• Device Lot Number: 3061941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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
• Patient Outcome(s): Required Intervention