MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1125225-23

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 lesions in the left anterior descending (lad), diagonal and circumflex coronary arteries with 85% stenosis and heavy calcification.A 2.25x23 mm xience alpine stent delivery system (sds) was advanced but failed to cross the lesion in the 1st diagonal due to the patient anatomy.The 2.25x23 mm sds was withdrawn with no resistance when the stent dislodged in the proximal lad.Balloon angioplasty was performed to crush the stent against the vessel wall in the proximal lad.Post balloon angioplasty, the diagonal artery became completely occluded.No plaque shift was reported.An additional two xience alpine stents were implanted in the proximal and mid lad overlapping the crushed 2.25x23 mm stent.No treatment was performed for the occluded diagonal artery.There was no reported clinically significant delay in the procedure and no reported patient symptoms as a result of the occluded diagonal artery.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance the device was unable to be replicated in a testing environment 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 did not indicate a lot specific quality issue.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 difficult anatomy during advancement causing the reported failure to advance.Although the stent dislodged during the withdrawal of the device it is likely the interaction of the device with the difficult anatomy during the attempted advancement caused reported stent dislodgement and subsequent patient effects of device embedded, occlusion, and additional therapy/non-surgical treatment.The reported patient effect of occlusion is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7777191
• MDR Text Key: 116907060
• Report Number: 2024168-2018-06210
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Catalogue Number: 1125225-23
• Device Lot Number: 8020641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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
• Patient Outcome(s): Required Intervention