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

Model Number 1125400-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Event Description

It was reported that the procedure was performed to treat a lesion in the left main coronary artery.A 4x15mm xience alpine stent delivery system (sds) was advanced, and the stent was deployed.The sds was removed from the anatomy, but then the sds was reinserted and used for dilatation.The balloon of the sds only partially deflated and was removed along with an unspecified guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device code 2017 - reinsertion.It should be noted that the instructions for use (ifu) xience alpine everolimus eluting coronary stent system states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2017: re-insertion was added.

Manufacturer Narrative

The device was returned for analysis.The reported deflation issue was unable to be confirmed.The reported difficulty to remove was unable to be confirmed as it was based on operational circumstances.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2017/reinsertion removed.

• Brand Name: XIENCE ALPINE
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9916606
• MDR Text Key: 186364342
• Report Number: 2024168-2020-03270
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199615
• UDI-Public: 08717648199615
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: 1125400-15
• Device Catalogue Number: 1125400-15
• Device Lot Number: 7051641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1