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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER CATHETER, PERCUTANEOUS

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MEDTRONIC, INC LAUNCHER CATHETER, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Vascular Dissection (3160)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative

Journal article: iatrogenic aortocoronary dissection during percutaneous coronary intervention authors: john hung, joel p. Giblett journal: jacc: case reports year: 2021 reference: doi. Org/10. 1016/j. Jaccas. 2020. 10. 022. Date of publication. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article titled: iatrogenic aortocoronary dissection during percutaneous coronary intervention; investigation and management - was submitted for review. A patient was admitted to hospital with exertional chest pain and a diagnostic angiography demonstrated a severely stenosed, severely calcified lesion in the dominant, proximal right coronary artery (rca) beyond a "shepherd¿s crook¿ type tortuosity. The patient underwent an elective percutaneous coronary intervention (pci) to the rca. Due to the severe tortuosity of the lesion, a 0. 75 medtronic amplatz left guide catheter was selected as it provides better passive support. Access was obtained from the right radial artery and the amplatz guide catheter was inserted. Although there was no particular difficulty in engagement, the initial test injection demonstrated catheter-induced dissection of the aorta, just below the rca ostium, with residual flow still seen to the rca. Severe chest pain immediately developed, and the electrocardiogram showed marked inferior st-segment elevation. To treat the dissection, a non medtronic (mdt) guidewire was passed beyond the stenosis into the posterior descending artery. It was decided to stent to dissection simultaneously with the original stenosis. The stenosis was pre-dilated with 2. 5 x 15 mm and 3. 0 x 20 mm non-mdt sc balloons. At this stage, flow was lost in the rca, and the patient became hypotensive. Initial attempts to deliver a 3. 0 x 38 mm non mdt drug eluting stent were unsuccessful because of the tortuosity and calcification in the proximal artery. A 6-f non-mdt guide extension catheter was used to facilitate delivery of the stent, which was deployed at 16 atm. This covered both the target lesion and the ostium of the rca, with the intention of sealing the dissection plane. Stent expansion was optimized further with a 3. 5 x 20 mm non-mdt nc balloon deployed at 18 atm. Thrombolysis in myocardial infarction (timi) flow grade 3 was restored. However, there was still marked residual dissection in the aorta. A post procedure ct aortography demonstrated a large aortic dissection from below the rca in the right coronary cusp to the innominate vessel. The heart team decision was to continue with a conservative approach at that stage, with ongoing blood pressure control and repeat cross-sectional imaging the following day. The patient was transferred directly to the intensive care unit for monitoring. Further ct after 24 h showed almost complete resolution of the dissection. This finding suggests that the flap had been successfully sealed by the coronary stent, as expected. No further intervention was performed, and he was discharged home safely after an otherwise uncomplicated recovery. A follow-up ct aortogram in 1 year was recommended. It was later reported that this was an operator error rather than a fault with the catheter.

 
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Brand NameLAUNCHER
Type of DeviceCATHETER, PERCUTANEOUS
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 
EI  
091708734
MDR Report Key12312187
MDR Text Key266169402
Report Number1220452-2021-00034
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK132673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 08/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/12/2021 Patient Sequence Number: 1
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