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

Catalog Number 1120250-08

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a 90% stenosed, mildly tortuous and restenosed lesion in the mid left circumflex (lcx) coronary artery.Force was applied in the attempt to advance a 2.5x8mm xience alpine stent delivery system (sds) to the lcx and failed to cross the lesion due to resistance with the anatomy.An attempt was made to remove the sds but resistance with the guiding catheter was felt.The physician removed the sds and the guiding catheter with the sion guide wire jumped from the aorta.The stent implant was dislodged and was found in the mid left anterior descending (lad) coronary artery.Because it was difficulty to remove the stent implant from the vessel, a 3.0x12mm non-abbott dilatation catheter was used to crush the 2.5x8mm xience alpine stent in the mid lad directly.A 2.0x20mm non-abbott stent was used to treat the target lesion in the mid lcx.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported failure to advance and the reported difficult to remove was unable to be replicated in a testing environment as they were 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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement resistance was met with the 90% stenosed, mildly tortuous and restenosed lesion resulting in the reported failure to advance.During removal interaction with the guiding catheter and/or other devices resulted in the reported difficult to remove and ultimately resulted in the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9417624
• MDR Text Key: 169277817
• Report Number: 2024168-2019-14169
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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: 02/04/2021
• Device Catalogue Number: 1120250-08
• Device Lot Number: 8012441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: SION; GUIDE WIRE: SION
• Patient Outcome(s): Required Intervention