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

Catalog Number 1070275-48

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems Occlusion (1984); Ventricular Fibrillation (2130)

Event Date 08/08/2020

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The trek device referenced is being filed under a separate medwatch report#.

Event Description

It was reported that the procedure was performed to treat a non-calcified, moderately tortuous mid right coronary artery.A 2.75x48mm xience xpedition stent was deployed with good apposition.A 3.25x15mm trek balloon dilatation catheter was advanced with resistance noted with the anatomy then failed to cross the proximal end of the xience xpedition.The trek balloon became trapped at the proximal edge of the xience xpedition.A deep seating technique was attempted with an unspecified guiding catheter then the patient underwent ventricular fibrillation with no flow.The patient was treated successfully using chest compression to defibrillate.The flow was resolved with the disengagement of the deep seated guiding catheter.A 3.0 non-abbott balloon was then used successfully cross and post-dilatate to complete the procedure.There was no adverse patient sequela reported.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 other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the 3.25x15mm trek balloon dilatation catheter was advanced interaction of the deployed 2.75x48mm xience xpedition stent resulted in the reported difficult to advance and the reported difficult to remove.Additionally, the treatment appears 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.

Event Description

Additional information received subsequent to filing the initial report: the placement of the guide catheter caused the occlusion and ventricular fibrillation.No additional information was provided.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10477841
• MDR Text Key: 205145496
• Report Number: 2024168-2020-07265
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Catalogue Number: 1070275-48
• Device Lot Number: 9102241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREK RX 3.25 X 15MM; TREK RX 3.25 X 15MM
• Patient Outcome(s): Required Intervention