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

Catalog Number 1070275-48

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562); Material Deformation (2976); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  Injury  

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 similar incidents from this lot.It is possible that during advancement the inflation/deflation lumen became compromised (bent/kinked/stretched) thus compromising the inflation/deflation lumen resulting in the reported activation failure/expansion failure, deflation problem and the reported entrapment of device; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation failure including expansion failures and deflation problem cannot be determined.The reported material deformation and material separation appear to be related to circumstances of the procedure as attempts to remove the entrapped device resulted in the reported material deformation and ultimately resulted in the reported material separation.The treatments 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.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.The (b)(4) referenced is filed under a separate medwatch report number.

Event Description

It was reported that during a left anterior descending and left circumflex coronary artery intervention that was mildly tortuous and 90% stenosed, after pre-dilatation, the 2.75x48mm xience xpedition stent was advanced to the lesion and stent deployment initiated; however, during balloon inflation, the balloon would not go past 6 atmospheres (atm) and then failed to deflate.The device was attempted to be removed; however, it became stuck and the shaft separated.The stent became shortened but remained on the delivery system in the patient.A 2.5x12mm nc trek was advanced to assist with removal of the stent delivery system; however, that device also became stuck and the shaft separated.The patient was sent for coronary artery bypass graft surgery, where the devices, including the stent, were successfully removed.There was no additional information 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
• 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: 11050974
• MDR Text Key: 223141039
• Report Number: 2024168-2020-10795
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 1070275-48
• Device Lot Number: 9092342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HT BMW UNIVERSAL II 190CM X2
• Patient Outcome(s): Hospitalization; Required Intervention; Disability