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

Catalog Number 1070350-28

Device Problems Device Dislodged or Dislocated (2923); Failure to Deflate (4060)

Patient Problem Tachycardia (2095)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned 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 similar incidents from this lot.The reported patient effect of tachycardia is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.As the device was not returned for analysis, the investigation determined a conclusive cause for the reported deflation problem cannot be determined.The reported stent dislodgment appears to be related to operational context of the procedure.The reported difficulties possibly contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the left main artery that was both moderately calcified and tortuous and 90% stenosed.The 3.50x28 mm xience xpedition stent was advanced and implanted in the lesion, without issue; however, the stent balloon failed to deflate.During attempted removal of the stent delivery system, the inflated balloon pulled the stent from the lesion into the aorta.The patient went into ventricular tachycardia and was intubated.A snare device was advanced to remove the balloon and stent.Both were captured by the snare, but the stent and balloon could only be pulled into the brachial artery.The surgeon was called to remove stent and balloon from the brachial artery.Once removed, the patient stabilized.There was no adverse patient sequela or a clinically significant delay in procedure.Another stent was successfully implanted in the lesion.On (b)(6) 2022, the patient was discharged from the hospital.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 15756918
• MDR Text Key: 303293219
• Report Number: 2024168-2022-11385
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070350-28
• Device Lot Number: 1113041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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
• Patient Age: 51 YR
• Patient Sex: Male