MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number G53971

Device Problem Positioning Problem (3009)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/28/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): k171513.Summary of investigational findings: due to narrowing of the true lumen of the descending aorta, there was a need to enhance the fitting of the zta junction with a coda balloon.Access was gained from the left femoral artery with the another les wire guide, tscmg-35-300-e-lesdc (complaint device).The following advancement of the coda balloon meet difficulties due to high degree of tortuosity in the descending aorta and the user pushed the wire guide proximally.It is understood that an injury/rupture occurred at the distal part of the descending aorta at the time the user pushed the wire guide proximally.A drop in blood pressure was observed and the patient had cardiac arrest and expired.No product was returned and no imaging could be obtained and therefore the investigation is based on the limited information provided only.However, vascular injury, including rupture, is a known potential adverse event using wire guides.Based on the current information provided it seems possible that the cause of the event could be due to a combination of difficult patient anatomy, patient pathology (the dissection), and procedural problem.There is no obvious indication of device failure.It was not possible to use contrast media in combination with fluoroscopy due to patient allergy, but it is assumed that the wire guide was advanced and positioned using the ivus (described for placement of the stent grafts).There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because any discovered non-conformances were dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: after an approach from the right femoral artery was gained with the first tscmg-35-300-e-lesdc(e4202485), the two zenith thoracic alpha (zta-pt-36-32-209-w1/e4055076 and zta-pt-32-28-201-w1/e4211066) were placed from just below the left common carotid artery to just above the celiac artery (for the primary entry closure).Thereafter, the two endurant ii aortic extensions were placed in the abdominal aorta (for re-entry closure).Due to allergy to contrast media, ivus (intravascular ultrasound) was used to confirm the position of the branches.Four of the above stent grafts were implanted in the planned position.Due to the narrowing of the true lumen of the descending aorta, there was a need to enhance the fitting of the thoracic alpha junction.So, after an approach from the left femoral artery was gained with the second tscmg-35-300-e-lesdc(e4202485), touch up with a coda balloon (coda-2-10.0-35-120-40/14095690) was planned to be performed.An approach from left femoral artery was gained, the reported coda balloon catheter could not be advanced due to high degree of tortuosity of descending aorta,.Injury/tear (rupture) occurred, which was at the site of tortuosity from the terminal aorta level to the left common iliac artery, when the user proximally pushed up the wire guide (the second lunderquist) which was passing through the reported coda balloon.Patient outcome: a drop in blood pressure was observed, and cardiac massage was given, but cardiac arrest occurred soon after.(on the way, contrast was performed to confirm the rupture site).The patient died.Additional information received 15mar2022: the coda balloon was not inflated when it was passing over the lunderquist wire and the issue occurred.

• Brand Name: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 13859837
• MDR Text Key: 287664520
• Report Number: 3002808486-2022-00205
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002539716
• UDI-Public: (01)00827002539716(17)261228(10)E4202485
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2022

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 Model Number: G53971
• Device Catalogue Number: TSCMG-35-300-E-LESDC
• Device Lot Number: E4202485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Female