MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012272-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The reported patient effect of dissection is listed in the coronary dilatation catheters (cdc), trek rx, instruction for use as a known patient effect.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.The additional treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately tortuous and heavily calcified lesion in the proximal circumflex artery.The lesion was pre-dilated with a 2.5x20mm trek rx balloon dilatation catheter (bdc).A 2.5x23mm xience sierra stent delivery system (sds) was advanced; however, failed to cross due to resistance with the anatomy.A 2.25x15mm xience sierra was advanced and deployed.A small dissection was noted, and ballooning was performed.Post procedure, angio was reviewed and it was noted that the dissection occurred after pre-dilatation with the 2.5x20mm trek rx bdc.The 2.5x23mm xience sierra sds never reached the lesion site or dissection.Angio review confirmed that the dissection was successfully treated with the deployment of the 2.25x15mm xience sierra and ballooning.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11141366
• Report Number: 2024168-2021-00268
• Device Sequence Number: 13611053
• Product Code: LOX
• UDI-Device Identifier: 08717648138300
• UDI-Public: 08717648138300
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1012272-20
• Device Catalogue Number: 1012272-20
• Device Lot Number: 00731G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention