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 Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/28/2022

Event Type  Death  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.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 the right coronary artery (rca) with no calcification or tortuosity and 85% stenosis.Pre-dilatation was performed with a 2.5x15 mm balloon and the 3.5x28 mm xience xpedition stent delivery system (sds) was advanced to the lesion.During the first inflation, the balloon did not inflate at all.Upon the second inflation to 12-16 atmospheres, the balloon was normally inflated but the balloon could not be deflated at all.Negative pressure was held the whole time.Contrast mix was 1:2.Attempts to deflate the balloon by changing the pressure pump were unsuccessful as well as attempts to puncture the balloon with a reverse needle.Additionally, attempts to puncture the balloon with an atrial needle were unsuccessful as well as attempts to puncture the balloon with a hard tip, and attempts to cut the balloon with a 5fr catheter placed in 6fr catheter modified blade were unsuccessful.Surgery was proposed to the family but they did not agree so a 5fr catheter was placed in a 6fr catheter modified blade to cut off the balloon rod and leave the balloon and stent in the anatomy.The guiding catheter was removed, the operation concluded and the patient was admitted to the cardiac care unit for observation.The issue caused occlusion of the rca and the patient expired.No additional information was provided.

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.A medical review was performed by an abbott vascular clinical specialist.The reviewer concluded the following: the procedural error of not removing, inspecting, and replacing the xience xpedition after the first failed inflation attempt and the failure to follow the ifu by using the incorrect saline/contrast mixture of 1:2, led to the xience xpedition being an indirect cause of the patient¿s death.The investigation was unable to determine a conclusive cause for the reported inflation and deflation issues.The patient effects of occlusion and death as well as the subsequent treatments appear to be related to operational context of the procedure.Without the cine images to review or the device returned for inspection, it cannot be definitively stated that the xience xpedition was a direct cause of this patient¿s death.However, this 3.5 x 28mm xience xpedition was an indirect cause of the patient¿s death.The procedural error of not removing, inspecting, and replacing the xience xpedition after the first failed inflation attempt and the failure to follow the ifu by using the incorrect saline/contrast mixture of 1:2, led to the xience xpedition being an indirect cause of the patient¿s death.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

N/a.

Event Description

It was reported that the procedure was to treat the right coronary artery (rca) with no calcification or tortuosity and 85% stenosis.Pre-dilatation was performed with a 2.5x15 mm balloon and the 3.5x28 mm xience xpedition stent delivery system (sds) was advanced to the lesion.During the first inflation, the balloon did not inflate at all.Upon the second inflation to 12-16 atmospheres, the balloon was normally inflated but the balloon could not be deflated at all.Negative pressure was held the whole time.Contrast mix was 1:2.Attempts to deflate the balloon by changing the pressure pump were unsuccessful as well as attempts to puncture the balloon with a reverse needle.Additionally, attempts to puncture the balloon with an atrial needle were unsuccessful as well as attempts to puncture the balloon with a hard tip, and attempts to cut the balloon with a 5fr catheter placed in 6fr catheter modified blade were unsuccessful.Surgery was proposed to the family but they did not agree so a 5fr catheter was placed in a 6fr catheter modified blade to cut off the balloon rod and leave the balloon and stent in the anatomy.The guiding catheter was removed, the operation concluded and the patient was admitted to the cardiac care unit for observation.The issue caused occlusion of the rca and the patient expired.Subsequent to the initially filed report, the following information was provided: the patient was admitted to the emergency department and after relevant examinations the patient was sent to the catheterization room for right coronary intervention.A non-abbott guide wire was advanced to the distal right coronary artery and pre-dilatation was performed at 10-12 atmospheres.It was confirmed by angiography that the guide wire had reached the lesion.The xience xpedition stent was released at 12 atmospheres after it was confirmed by angiography to have reached the lesion.The contrast mix was reported to be 1 part contrast to 2 parts saline.No additional information was provided.

Manufacturer Narrative

H6 medical device problem code 2017: contrast incorrect.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 the xience xpedition stent delivery system (sds) contrast mix was reported to be 1 part contrast to 2 parts saline.The xience xpedition everolimus eluting coronary stent system instructions for use (ifu) states delivery system preparation to use 1:1 mix with normal saline.A medical review was performed by an abbott vascular clinical specialist.The reviewer concluded the following: this was a case to treat the right coronary artery (rca) of a 73 year old female patient.The rca was reported to have an 85% stenosis and to not be calcified or tortuous.After successful pre-dilatation with an unspecified 2.5 x 15mm balloon dilatation catheter, the 3.5 x 28mm xience xpedition des was advanced to the lesion in the rca.The xpedition des reportedly failed to inflate with the first attempt, the xpedition des should have been removed from the patient¿s vessel and inspected for kinks or any damage to the catheter before attempting to use the device again.However, without removing and inspecting the device, a second inflation attempt was reportedly successful and appeared to be a normal inflation.Unfortunately, the stent balloon would not deflate.Multiple attempts to deflate the balloon were made, but all were unsuccessful.A surgical intervention was deemed necessary by the physician, but the family declined.The xpedition stent balloon catheter was cut inside and left within the patient¿s rca.The balloon occluded the rca and the patient expired later that same day.Without the cine images to review or the device returned for inspection, it cannot be definitively stated that the xience xpedition was a direct cause of this patient¿s death.However, this 3.5 x 28mm xience xpedition was an indirect cause of the patient¿s death.The reported patient effects of death and 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 inflation and deflation issues.The patient effects of occlusion and death as well as the subsequent treatments appear to be related to 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: 14160463
• MDR Text Key: 289692817
• Report Number: 2024168-2022-04236
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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: 05/04/2022
• 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
• Treatment: ASAHI SION GUIDE WIRE
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 70 KG