MAUDE Adverse Event Report: ABBOTT VASCULAR RX PRIME; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1011709-18

Device Problems Inflation Problem (1310); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problems Cardiogenic Shock (2262); Foreign Body In Patient (2687)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 should be noted that the xience prime, everolimus eluting coronary stent system instructions for use (ifu) states: pre-dilate the lesion with a percutaneous transluminal coronary angioplasty (ptca) catheter of appropriate length and diameter for the vessel/lesion to be treated.The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling resulted in the reported material separation; thus resulting in the reported difficult or delayed activation/difficult to deploy and inflation problem.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient presented with inferior wall myocardial infarction and 70-80% stenosis in the right coronary artery (rca).The 3.0x18 mm xience prime stent was attempted to be deployed; however, the pressure was unable to be increased past 8 atmospheres and the stent was not fully expanded.The proximal and distal ends expanded correctly but not the middle portion.The physician changed the inflation device but there was no change.The delivery system was slowly deflated and when the delivery system was withdrawn only the shaft came out and a portion of the shaft remained in the patient.It was attempted to remove the balloon with a snare but it failed.The patient was sent for coronary artery bypass graft (cabg), but during the transfer, the patient experienced shock and was admitted to the icu on a ventilator.No additional information was provided.

• Brand Name: RX PRIME
• 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: 9940829
• MDR Text Key: 187519419
• Report Number: 2024168-2020-03522
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2022
• Device Catalogue Number: 1011709-18
• Device Lot Number: 9061841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR