MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number 1012451-12

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problem Intimal Dissection (1333)

Event Date 05/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number -(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The additional xience sierra device referenced is being filed under a separate medwatch report.Evaluation summary: visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed; however, the reported device damaged by another device could not be replicated in a testing environment as they are based on operational circumstances.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 and patient effects appear to be related to circumstances of the procedure.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu), states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm; therefore, rbp was exceeded.In this case, it is unlikely that the ifu deviation contributed to the reported event.The reported patient effect of dissection is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use as a known patient effect.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported the procedure was to treat a heavily calcified lesion in the right coronary artery (rca).A 3.25x23mm xience sierra stent was deployed at an unknown pressure in the proximal end of the rca into the ostium.Post dilatation was performed with a 3.50x12mm nc trek balloon dilatation catheter at the proximal end of the stent in an attempt to flare the stent out into the ostium.The balloon was inflated to 18 and then 20 atmospheres.On the third inflation at 16 atm, the balloon ruptured and a dissection was noted.Another sierra stent was deployed overlapping the first stent as treatment.In the physicians opinion, the balloon material caught on the stent strut during inflation, causing the rupture and subsequent dissection.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8662993
• MDR Text Key: 146807385
• Report Number: 2024168-2019-04296
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151972
• UDI-Public: 08717648151972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 1012451-12
• Device Lot Number: 90401G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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
• Treatment: 3.25X23 XIENCE SIERRA STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 112