MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX; CORONARY DILATATION CATHETER

Catalog Number 1012449-12

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838); Hematoma (1884)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2019, to treat a lesion in the mid right coronary artery (rca).Two 3.5x38mm xience sierra stents were implanted.During the procedure, a severe, multilater deep wall dissection and hematoma were noted.No treatment was performed and the event resolved on (b)(6) 2019.There was no additional information provided.

Manufacturer Narrative

G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Device code 2017 - above rbp.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It was reported that the nc trek bdc was overinflated to 24 atmospheres (atms) during inflation.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm.It is undetermined if the ifu deviation contributed to the reported event.The reported patient effects of intimal dissection and hematoma are listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use as known patient effects.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 the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was provided: prior to stent implantation, an nc trek balloon was inflated to 24 atmospheres to open the lesion.The optical coherence tomography (oct) catheter was advanced.It was noted that there was extensive amount of dissection and subintimal bleeding.Two stents were then implanted in the lesion and the stents post-dilated.Although some extravasation remained, the decision was made to let the vessel heal on its own, in order to not cause any additional vessel damage.No additional information was requested.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9274527
• MDR Text Key: 165089486
• Report Number: 2024168-2019-13180
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 1012449-12
• Device Lot Number: 81022G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XIENCE SIERRA, 3.5X38MM
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 77