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

Model Number 1804250-15

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

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

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous and heavily calcified lesion in the mid right coronary artery (rca).Pre-dilatation was attempted with a 1.2mm balloon dilatation catheter (bdc) however the device failed to cross to the lesion.The 2.50x15mm rx xience skypoint stent delivery system (sds) was advanced and failed to cross the lesion.During removal the stent dislodged in the proximal rca.Another balloon catheter was advanced and slightly inflated to trap the dislodged stent and bring it back into the guide liner and then subsequently removed.The procedure was aborted and the patient will return at a later time for further treatment.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance 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 mildly tortuous and heavily calcified lesion causing the reported failure to advance.During removal the stent dislodged and was successfully removed using a balloon catheter.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 13030251
• MDR Text Key: 282485400
• Report Number: 2024168-2021-11830
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: 08717648233074
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 1804250-15
• Device Catalogue Number: 1804250-15
• Device Lot Number: 1072141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2021
• 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
• Treatment: 6FR GUIDE LINER
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male