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

Model Number 1125400-15

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 performed to treat a lesion in the right coronary artery.A 4.0x18mm xience alpine stent delivery system (sds) failed to cross due to resistance with the anatomy.The sds was removed.A 4.0x15mm xience alpine sds was advanced through a non-abbott microcatheter; however, resistance was felt with both the microcatheter and the anatomy.The sds was forcefully pulled back into the microcatheter and an attempt to advance it further was made.After advancing the microcatheter an attempt to advance the sds again was made, but resistance was felt and the sds was forced out of the microcatheter resulting in stripping the stent off of the balloon leaving it behind in the microcatheter.It was noted that the stent was not on the balloon right away and was able to remove the sds through the microcatheter retrieving the stent with the stent balloon on the way out.The procedure was successfully complete with a 4.0x12mm xience alpine stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to advance, difficult to remove and failure to advance could not be tested due to the condition of the returned device.It should be noted that the xience alpine everolimus eluting coronary stent system, domestic instructions for use (ifu) states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Resistance may indicate a problem and the use of excessive force may result in stent damage or dislodgement.Maintain guide wire placement across the lesion and remove the delivery system and guiding catheter as a single unit.It is unknown the ifu deviation directly caused or contributed to the reported issues.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 incidents.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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
• MDR Report Key: 10241971
• MDR Text Key: 198554736
• Report Number: 2024168-2020-05527
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 1125400-15
• Device Catalogue Number: 1125400-15
• Device Lot Number: 8052141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: TELESCOPE (MEDTRONIC)