MAUDE Adverse Event Report: MEDTRONIC, INC ADVANCE; CATHETER, EMBOLECTOMY

Catalog Number UNK-CV-DAN-EXP-ADV

Device Problem Suction Problem (2170)

Patient Problem Injury (2348)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

From literature article: patient was admitted because of a latecomer infero-lateral stemi.A critical stenosis in the mid segment of the rca, complicated by a high thrombotic burden at the middle segment and 100% posterolateral (pl) branch thrombotic occlusion were found.Despite late presentation, it was decided to intervene percutaneously because of ongoing chest pain, persistent st segment elevation and hemodynamic and electrical instability characterized by hypotension and recurrent runs of non-sustained ventricular tachycardia.After engaged the rca with a 6-fr jr4 non-medtronic guide catheter was easily crossed with a non-medtronic guidewire.Initially, the pl branch was dilated with a 2.0 mm semi compliant balloon without improving vessel perfusion.(thrombolysis in myocardial infarction, timi 0 flow).Afterwards, it was decided to thromboaspirate.However, despite repeated long manual aspirations with an export 6-fr advance catheter and multiple 2.0 mm semi-compliant balloon inflations, coronary flow could not be re-established.Due to ongoing chest pain associated with hemodynamic and electrical instability, salvage thrombectomy was required to restore coronary perfusion.Therefore, the jr4 guide catheter was carefully advanced over the export catheter up to the ostium of the pl branch.After completely removing the export device, a direct aspiration from the ultra-deep intubated guide catheter through a 30 cc luer-lock syringe allowed to obtain a huge organized clot which resulted in distal timi 3 flow restoration revealing critical stenosis along the pl branch.No signs of iatrogenic dissection along the rca were observed.Finally, a non-medtronic drug eluting stent was deployed in the pl branch achieving an excellent angiographic result with timi 3 flow.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADVANCE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9614865
• MDR Text Key: 185908521
• Report Number: 1220452-2020-00007
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K152335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-DAN-EXP-ADV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR