MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070300-48

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat the mid left anterior descending (lad) coronary artery with heavy calcification.Several pre-dilatations were performed and the 3.0x48 mm xience xpedition stent delivery system (sds) was advanced to the lesion and resistance was noted with a non-abbott guide catheter extension.The delivery system was inflated once to 10 atmospheres, and the stent was deployed.Deflation was attempted but there was no pressure reduction.Negative pressure was applied several times for 10-20 seconds.Several bail out techniques were attempted but were not successful and there was resistance still during removal and the balloon would not move.During this process, the hypotube separated and was taken out of the patient but the balloon was still inflated.A snare was attempted but was unsuccessful.The patient was then sent to surgery for coronary artery bypass surgery to cut the left main to the lad and the balloon was removed.The patient was hospitalized additional time.The stent remains implanted.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported shaft separation was confirmed.The reported difficulty to advance and difficulty to remove could not be replicated in a testing environment as they are related to operational context of the procedure.The reported failure to deflate could not be confirmed due to the condition the device was received 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 investigation determined the reported difficulty to advance (guiding catheter and anatomy), difficulty to remove, shaft separation and treatment appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported deflation issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION 48 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: 18113557
• MDR Text Key: 327878498
• Report Number: 2024168-2023-12517
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070300-48
• Device Lot Number: 3032241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2023
• 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
• Treatment: ASAHI SION BLUE 0.014
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Weight: 47 KG