MAUDE Adverse Event Report: ABBOTT VASCULAR PRESSUREWIRE¿ X GUIDEWIRE; CATHETER TIP PRESSURE TRANSDUCER

Catalog Number UNK PRESSUREWIRE X GUIDEWIRE

Device Problem Difficult to Advance (2920)

Patient Problems Hematoma (1884); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 12/13/2021

Event Type  Injury  

Event Description

It was reported in an article, that an unspecified pressurewire was advanced to a lesion in the left anterior descending (lad) artery using a 4.0 guiding catheter to perform a an invasive assessment of the coronary microcirculation.The patient presented with angina, dyspnea, and ischemia.Coronary thermodilution curves under resting conditions were successfully obtained by repeated intracoronary bolus injections of 3 ml of saline at room temperature; however, insufficient curves were obtained during hyperemia.After the fractional flow reserve dropped to 0.39, ccta showed left main coronary artery (lmca) dissection with lad occlusion, indicating the national heart, lung and blood institute (nhlbi) classification type f dissection due to inadvertent deep-seating of the guiding catheter and the thermodilution procedure.Further, the pressurewire was inadvertently removed and not advanced easily into the distal lad.Another guiding catheter was additionally engaged in the anatomy.After crossing the left circumflex artery (lcx) with a 0.014-inch non-abbott floppy guidewire, intravascular ultrasound (ivus) catheter was advanced into the left circumflex artery and the false lumen of the lad.It showed intramural hematomas compressing the true lumina of the arteries.An additional guidewire was successfully inserted into the true lumen of the lad under real-time ivus guidance.Because of the difficulty encountered in achieving optimal stenting, fenestrations between the true lumen and hematomas were planned, balloon dilation was performed.A cutting balloon was used for off-label treatment of the dissection.Ivus showed regression of the hematoma and the residual dissection with false lumen formation.After the procedure, the angina was resolved.No other information was provided.

Manufacturer Narrative

The device was not returned.The lot history record for this product could not be reviewed because the product was not returned for evaluation and the part and lot number was not reported.The information received in the complaint was obtained from an article.Difficulty crossing a lesion and difficulty to remove can be affected by numerous factors including, but not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, incorrect guide catheter size, and accessory device support.A definitive cause for the difficulty advancing could not be determined.Additionally, a cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effects of dissection and occlusion are listed in the pressurewire instruction for use as potential complications which may be encountered during all catheterization procedures.In this case, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Date of event is estimated as (b)(6) 2021.The udi number is ¿ni¿ as the catalog number was not provided.Attached article titled, "treatment of an iatrogenic left main coronary artery dissection and intramural hematoma by fenestration instead of stent implantation.".

• Brand Name: PRESSUREWIRE¿ X GUIDEWIRE
• Type of Device: CATHETER TIP PRESSURE TRANSDUCER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15067474
• MDR Text Key: 296251801
• Report Number: 2024168-2022-07944
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK PRESSUREWIRE X GUIDEWIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female