MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1120400-18

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The incident information was reviewed, however, the product was not returned to abbott vascular 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 other similar incidents, and/or complaints reported from this lot.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use (ifu) instructs to remove the sds from the protective tubing and remove the protective sheath prior to preparing the sds for use.In this case the reported incorrect preparation sequence of the sds did not cause, or contribute to the reported stent dislodgement issue.The investigation determined the reported stent dislodgement appears to be related to a combination of operational circumstances of the procedure and user technique.Based on the reported information, it is likely that the technique, or grasp of the user to remove the protective sheath, was too rough, or tight resulting in the stent dislodgement in the protective sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that a 4.0x18mm xience alpine stent delivery system (sds) was unpacked, and prepared before removing the sheath/stylet.The protective sheath was removed without resistance, however, the stent dislodged off the balloon, and was located in the protective sheath.The sds was not used, and there was no patient involvement.The procedure was successfully completed with a new unspecified xience alpine stent.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT 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: 10698015
• MDR Text Key: 211945382
• Report Number: 2024168-2020-08692
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Catalogue Number: 1120400-18
• Device Lot Number: 9112041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1