MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE; HAP WIRE GUIDE

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Article: foerst et al., "percutaneous repair of left ventricular wire perforation complicating transcatheter aortic valve replacement for aortic regurgitation", cardiovascular intervention, 2016.Name and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to article: "the follow-up echocardiogram was notable for a new left ventricular apical perforation with pseudoaneurysm (psa).The perforation was presumed to be from the motion of the delivery system delivered over a shaped lunderquist wire (cook medical).The psa enlarged over the following 2 days, so given the patient¿s prohibitive surgical risk, we decided to treat percutaneously.An 8-f torque view guide (st.Jude medical) was advanced to the left ventricle over a j wire that was directed into the left ventricular psa.Multipurpose catheter was advanced through the torque view over the j wire into the psa, and the delivery catheter was advanced over the multipurpose catheter.The multipurpose catheter and wire were removed, and a 10-mm amplatzer muscular ventricular septal defect occluder (st.Jude medical) was deployed.There was a trivial residual leak.At 4-month follow-up, the patient¿s dyspnea was improved and the psa space stable, with a small residual color jet on echocardiography." patient outcome: patient did require additional procedures due to this occurrence.Adverse effects on the patient to this occurrence: formation of a pseudoaneurysm (a secondary procedure was performed which stabilised the pseudoaneurysm).

Manufacturer Narrative

Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on article and image review.Cta and angiographic images of the ventricular pseudoaneurysm demonstrate a left ventricular apical pseudoaneurysm neck just superior to a focus af apical thinning.Given the history of bypass grafting to the left anterior descending (lad) artery, the perforation likely occurred at the superior margin of an apical scar.Although the neck diameter measured 4mm on the cta image, it was 5mm on the angiographic images.A ventricular perforation causing a pseudoaneurysm is confirmed.The report implicates the evolut r delivery system rather than the lunderquist wire as the cause and the imaging provided supports that conclusion.The wire was either just projecting beyond the evolut r tip when the perforation occurred or a tight loop of the floppy tip was pushed by the evolut r through a partially thinned left ventricular apex that was too weak to bend or kink the wire.Significant findings relative to the disease state were observed; acute left apical thinning just inferior to the perforation supports a ventricular apex weakened from scarring.Significant findings relative to the use of the device were observed; because the event was not recognized when it occurred, either enough wire was not projecting out of the evolut r when the perforation occurred or a loop of the floppy tip was pushed through the apex without being fluoroscopically observed.Based on the article/image review there is no evidence to suggest that the lunderquist wire guide was not manufactured according to specifications and performed as intended.Cook medical will continue to monitor for similar events.

• Brand Name: LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE
• Type of Device: HAP WIRE GUIDE
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7094764
• MDR Text Key: 94129168
• Report Number: 3002808486-2017-02357
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/16/2017
• Date Manufacturer Received: 01/24/2018
• 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): Life Threatening
• Patient Age: 74 YR