MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY¿ OPTIS¿ IMAGING CATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number C408646

Device Problems Entrapment of Device (1212); Poor Quality Image (1408); Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 06/06/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified right coronary artery (rca).A xience alpine 2.75x38mm was implanted in the distal rca, and a xience alpine 3.0x38mm stent was deployed proximal to it.Resistance met during advancement of the dragonfly optis catheter, and the lens was damaged (noticed as soon as put on live mode).An attempt was made to remove the catheter, but it was stuck in the distal alpine (2.75x38) stent.The catheter had to be cut and a guide liner was advanced into the anatomy to pull the catheter out.During removal of the catheter, a dissection occurred, and the struts of both alpine stents were damaged.To treat the dissection, two alpine 2.5x38mm stents were deployed overlapping the distal 2.75x38mm stent.After this a large thrombus formed in both the proximal and distal stent, and there was no flow in the rca.Thrombus aspiration was performed.A proximal dissection was suspected.A 3.0x38 alpine stent was deployed in the proximal segment.Two additional alpine stents (3.0x33 and 2.25x18) were also deployed to treat the dissections, but flow was not restored.The no flow was managed with tirofiban infusion and heparin.The patient remained hemodynamically stable, and the procedure was aborted.Final shots showed a minimum flow in the rca.Two days after the procedure, the patient had some changes in the electrocardiogram, so the patient was under observation.No additional information was provided.

Manufacturer Narrative

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 revealed no other incidents and/or complaints reported from this lot.Based on the information, the reported difficulty to advance, entrapment of device, damage caused to another device, and imaging issue as a result of damage to the lens appear to be due to circumstances of the procedure.It is likely that the dragonfly catheter interacted with the two overlapping xience alpine stents in the heavily calcified right coronary artery (rca) resulting in resistance during advancement and entanglement with the stents.As a result, damage to the dragonfly optis lens likely occurred resulting in the reported imaging issue.The reported patient effect of vascular dissection is listed in the dragonfly optis instruction for use as a known complication that may occur as a consequence of intravascular imaging.A cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The unexpected medical intervention to treat the damaged stents and vessel dissection were related to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience alpine stents (2.75x38mm, 3.0x38mm) referenced are filed under separate medwatch report numbers.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14876366
• MDR Text Key: 295057169
• Report Number: 2024168-2022-07076
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8131267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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: XIENCE ALPINE STENT: 2.75X38 MM; XIENCE ALPINE STENT: 3.0X38 MM
• Patient Outcome(s): Required Intervention