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

Catalog Number 1070275-28

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Migration (4003); Failure to Deflate (4060)

Patient Problems Angina (1710); Cardiac Arrest (1762); Obstruction/Occlusion (2422)

Event Date 04/23/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly calcified lesion in the left anterior descending (lad) coronary artery.The 2.75x28 mm xience xpedition stent delivery system (sds) was not prepped outside the anatomy.The sds was advanced and when the balloon was attempted to be inflated after stent placement, the balloon failed to inflate to deploy the stent.Another inflation device was attempted, and during inflation only the proximal portion of the stent expanded, the distal portion did not open up.The physician attempted to deflate the balloon but it would not deflate and the patient experienced chest pain.Inflation was attempted again, this time with higher pressure which fully inflated the stent.Again deflation was attempted and negative was held for 4 minutes but was unsuccessful, and the vessel was occluded.The inflation device was disconnected and a syringe was attempted to deflate the balloon which also failed.The stent balloon was dotted with a guide wire and this was unsuccessful and a guide wire was inserted to attempt to puncture the balloon but the guide wire could not reach the balloon.The total time taken was close to 15 minutes which led to the patient having cardiac arrest and had to be resuscitated with cpr.Finally the entire assembly (guide wire, guide catheter) was pulled back into the aorta and removal was attempted but there was resistance with the sheath.The hypotube was cut but still the device could not be removed until force was used and the entire system was removed.The patient recovered well; however, a final angiography showed that the stent had migrated from the deployed position but remains in the target lesion.The result was accepted and the procedure completed and the patient was hospitalized for an additional day.No additional information was provided.

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.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 to treat a mildly calcified lesion in the left anterior descending (lad) coronary artery.The 2.75x28 mm xience xpedition stent delivery system (sds) was not prepped outside the anatomy.The sds was advanced and when the balloon was attempted to be inflated after stent placement, the balloon failed to inflate to deploy the stent.Another inflation device was attempted, and during inflation only the proximal portion of the stent expanded, the distal portion did not open up.The physician attempted to deflate the balloon but it would not deflate and the patient experienced chest pain.Inflation was attempted again, this time with higher pressure which fully inflated the stent.Again deflation was attempted and negative was held for 4 minutes but was unsuccessful, and the vessel was occluded.The inflation device was disconnected and a syringe was attempted to deflate the balloon which also failed.The stent balloon was dotted with a guide wire and this was unsuccessful and a guide wire was inserted to attempt to puncture the balloon but the guide wire could not reach the balloon.The total time taken was close to 15 minutes which led to the patient having cardiac arrest and had to be resuscitated with cpr.Finally the entire assembly (guide wire, guide catheter) was pulled back into the aorta and removal was attempted but there was resistance with the sheath.The hypotube was cut but still the device could not be removed until force was used and the entire system was removed.The patient recovered well; however, a final angiography showed that the stent had migrated from the deployed position but remains in the target lesion.The result was accepted and the procedure completed and the patient was hospitalized for an additional day.Subsequent to the initially filed report, the following information was provided: the device was not prepped at all.

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.It was reported that the device was not prepared (air aspiration) before use.It should be noted that the xience xpedition instructions for use (ifu) states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.In this case, it is unknown if the ifu deviation contributed to the reported event.The reported patient effects of angina and obstruction/occlusion are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulties.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatments and delay to treatment/therapy appear 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.

• 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: 14345974
• MDR Text Key: 291290754
• Report Number: 2024168-2022-05073
• 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,Followup
• Report Date: 06/17/2022

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 Catalogue Number: 1070275-28
• Device Lot Number: 1111141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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): Hospitalization; Life Threatening; Required Intervention