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

Model Number	1012275-15
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Codes	Occlusion (1984); Ventricular Fibrillation (2130)
Date of Event	08/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The xience xpedition device referenced is being filed under a separate medwatch report#.
Event or Problem Description
It was reported that the procedure was performed to treat a non-calcified, moderately tortuous mid right coronary artery.A 2.75x48mm xience xpedition stent was deployed with good apposition.A 3.25x15mm trek balloon dilatation catheter was advanced with resistance noted with the anatomy then failed to cross the proximal end of the xience xpedition.The trek balloon became trapped at the proximal edge of the xience xpedition.A deep seating technique was attempted with an unspecified guiding catheter then the patient underwent ventricular fibrillation with no flow.The patient was treated successfully using chest compression to defibrillate.The flow was resolved with the disengagement of the deep seated guiding catheter.A 3.0 non-abbott balloon was then used successfully cross and post-dilatate to complete the procedure.There was no adverse patient sequela reported.No additional information was provided.
Event or Problem Description
Additional information received subsequent to filing the initial report: the placement of the guide catheter caused the occlusion and ventricular fibrillation.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported failure to advance and difficult to remove were unable to be replicated in a testing environment as they were 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 appear to be related to circumstances of the procedure as it is likely that resistance was met with the anatomy and/or the proximal edge of the previously deployed xience xpedition resulting in the reported failure to advance and difficult to remove.The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis.Additionally, the treatment 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.

• Brand Name: TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10477867
• Report Number: 2024168-2020-07268
• Device Sequence Number: 11483108
• Product Code: LOX
• UDI-Device Identifier: 08717648138508
• UDI-Public: 08717648138508
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1012275-15
• Device Catalogue Number: 1012275-15
• Device Lot Number: 80704G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XIENCE XPEDITION DES 2.75X48 RX; XIENCE XPEDITION DES 2.75X48 RX
• Outcome Attributed to Adverse Event: Required Intervention