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

Catalog Number 1078250-48

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562)

Patient Problems Bradycardia (1751); Death (1802); Myocardial Infarction (1969); Heart Failure (2206)

Event Date 05/28/2020

Event Type  Death  

Manufacturer Narrative

The device has not been received yet.A follow-up report will be submitted with all additional relevant information.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a diffuse lesion located in the distal right coronary artery (rca) to the posterior descending branch that was mildly tortuous, non-calcified, and 75% stenosed.The 2.5 x 48 xience xpedition stent delivery system (sds) was advanced to the lesion and deployed at 10 atmospheres; however, the stent balloon failed to deflate.Additionally, the sds was stuck in the vessel and could not be removed.Trouble shooting was attempted to deflate the balloon and remove the device, but all was unsuccessful and during the attempts, the distal portion of the sds separated, so the patient was taken for bypass surgery.The patient remained hospitalized, in guarded condition; however, on (b)(6) 2020 the patient died.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported material separation was confirmed, the reported deflation problem was unable to be tested due to the condition of the returned unit.The reported device entrapment could not be evaluated as the anatomical conditions encountered by the device during the procedure could not be replicated in a testing environment.The device functional testing performed was unable to confirm the presence of an obstruction in the catheter that could have contributed to the deflation problem.A review of the complaint history identified no similar incidents from this lot.The reported patient effects of myocardial infarction, arrhythmia (including atrial and ventricular), heart failure and death, are listed in the everolimus eluting coronary stent system (eecss) xience xpedition 48 instruction for use as known possible complications that may occur with the use of the device.An abbott vascular medical affairs expert reviewed the case details and concluded: 1.A fault in the xience stent delivery system is a possibility but cannot be confirmed based on the condition of the returned device; 2.Unsuccessful attempts were made to deflate the balloon, but 4 hours elapsed before a surgical solution was considered; 3.The patient passed away owing to consequences associated with right ventricle (rv) infarction, presumably related to prolonged right coronary artery (rca) occlusion, and aggravated by pre-existing left ventricular hypertrophy (lvh).The investigation was unable to determine a definitive cause for balloon deflation problem.It may be possible due to the device interaction with the anatomy, the outer member was stretched/kink causing the deflation balloon problem which subsequently caused the device entrapment.The patient effects of myocardial infarction, bradycardia, heart failure and death may be due to procedural/patient's health conditions and physician¿s technique.The additional therapy / non-surgical treatment, surgical procedure and delay in procedure were due to procedural circumstances.The exact cause for the failure was not determined.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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
• MDR Report Key: 10155586
• MDR Text Key: 195214549
• Report Number: 2024168-2020-05042
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Catalogue Number: 1078250-48
• Device Lot Number: 0020441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 07/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR