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

Model Number 1804350-12

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 01/22/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a 90% stenosed lesion in the proximal left descending artery (plad) with heavy calcification.Pre-dilation was performed with a semi-compliant balloon and a cutting balloon.Then a 3.5 x 12 xience skypoint stent delivery system (sds) was advanced to the target lesion; however the stent became stuck in the lesion while attempting to position the stent.The stent was removed with the sds from the patient with a snare device.After the stent was removed from the patient, the struts were observed to be flared.A non-abbott sds was used to complete the procedure.No additional information was reported.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.The reported material deformation was confirmed.The inner and outer member appeared to be cut proximal to the proximal balloon seal.Follow up performed with the account indicated that the cut portion of the catheter occurred during the reported snaring process.The reported entrapment of the device 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 as it is likely the device interacted with the heavily calcified and 90% stenosed lesion causing the reported entrapment of device.A snaring device was used to retrieve the stent delivery system (sds).Material deformation was reported after removal from the anatomy likely due to interaction with the difficult anatomy and/or interactions with the snaring device during removal.There is no indication of a product quality issue with respect to manufacture, design or labeling.Device code 1528 removed and device code 1212 was added.

• 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: 13542450
• MDR Text Key: 285684124
• Report Number: 2024168-2022-01601
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233388
• UDI-Public: 08717648233388
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: 1804350-12
• Device Catalogue Number: 1804350-12
• Device Lot Number: 1020241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2021
• 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