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

Catalog Number 1070250-48

Device Problem Deflation Problem (1149)

Patient Problems Ventricular Fibrillation (2130); Obstruction/Occlusion (2422)

Event Date 09/19/2021

Event Type  Injury  

Manufacturer Narrative

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, moderately tortuous, 80% stenosed, de novo lesion in the left anterior descending (lad) artery.A 2.5x48mm xience xpedition drug eluting stent (des) was advanced to the lesion and implanted without issue.The des balloon was inflated to 12 atmospheres (atm) and fully deflated.Subsequently, the balloon was inflated to 14 atm to post dilate the stent, but the balloon only partially deflated after several attempts, with negative pressure being held for 20 seconds each time.The balloon only deflated distally up until an acute bend in the anatomy and would not deflate any further, at which point no flow was observed.Femoral access was then gained to advance another wire to puncture the des balloon, but the patient experienced ventricular fibrillation and there was no time to complete the puncture strategy, instead, the deployer inflated the des balloon to 28 atm, in order to rupture the balloon and restore the blood flow.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.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.The reported patient effects of occlusion and ventricular fibrillation are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.A cine of the reported event was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the media provided confirmed the events of the complaint summary in which the proximal portion of the stent delivery system (2.5x48mm xience xpedition) balloon failed to deflate.The distal portion (~20%) of the sds balloon can be seen to deflate while the proximal portion (~80%) fails to deflate.The separation of the deflated and inflated portions of the sds balloon occurs at a tight bend in the patient¿s coronary anatomy where the artery pinches the balloon.This tight anatomical bend in the coronary artery is the probable cause for the event, preventing the full deflation of the sds balloon.Additionally, the patient effects of occlusion and ventricular fibrillation appear to be related to operational context.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem codes 2017 and 1546 were deleted.

Event Description

It was reported that the procedure was to treat a mildly calcified, moderately tortuous, 80% stenosed, de novo lesion in the left anterior descending (lad) artery.A 2.5x48mm xience xpedition drug eluting stent (des) was advanced to the lesion without issue.The balloon was inflated to 12 atmospheres (atm) and fully deflated.Subsequently, the balloon was inflated to 14 atm to post dilate the stent, but the balloon only partially deflated and no flow was observed.Femoral access was then gained to advance another wire to puncture the des balloon, but the patient experienced ventricular fibrillation and there was no time to complete the puncture strategy, instead, the deployer inflated the des balloon to 28 atm, in order to rupture the balloon and restore the blood flow.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.Subsequent to the initially filed report, the following information was provided: subsequent to inflating the balloon to 12 atm, the balloon was inflated to 14 atm to post dilate the stent, but the balloon only partially deflated after several attempts, with negative pressure being held for 20 seconds each time.The balloon only deflated distally up until an acute bend in the anatomy and would not deflate any further, at which point no flow was observed.No additional information was provided.

• 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: 12601506
• MDR Text Key: 276207716
• Report Number: 2024168-2021-09033
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1070250-48
• Device Lot Number: 1050641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention