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Model Number EUP2515X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Vascular Dissection (3160)
Event Date 11/16/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
During a pci procedure one 3. 5 x 22mm resolute onyx otw drug eluting stent was used to direct stent a mildly tortuous, moderately calcified lesion exhibiting 98% stenosis located in the proximal lad. The lesion in the proximal lad was a severe lesion. There was no damage noted to the packaging. There were no issues noted when removing the device from the hoop/tray. Negative prep was performed with no issues. The device did not pass through a previously deployed stent. The lesion was not pre-dilated. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. The 3. 5 x 22mm resolute onyx was inflated once to 15 atm. A decision was made not to go higher than 15atm because the stent was being over-sized. Preprocedure stenosis was 90% with timi 3 flow. Post procedure stenosis was 0% with timi 3 flow. It was indicated that the mid-section of the stent at the takeoff of the diagonal branch was not fully expanded. That area was post-dilated to expand the stent and the flow to the diagonal branch was compromised. There was a second wire placed in the diagonal branch and a 2. 0 x 15mm sprinter otw balloon was placed through the stent struts and inflated to 8atm to reinstate flow. Preprocedure stenosis was 80-90% with timi 3 flow. Post procedure stenosis was 10% with timi 3 flow. The procedure was successful. The initial pci procedure was completed without any issues except there was a mild waist in the mid stent area as full expansion was not achieved. It was reported that approximately 5 days post procedure, the patient presented with elevated troponin, chest pain, sob and nausea and was brought to the er and then transferred to ccl. The patient was in cardiogenic shock. The impression was that the patient had acute myocardial infarction caused by stent thrombosis. An angiogram revealed that the lad stent was closed along with no distal flow past the proximal stented area. It was thought to be stent thrombosis. The very proximal lad was occluded with a large burden of thrombus at the proximal edge of the stented portion. The lesion was predilated with a 2. 5 x15mm euphora balloon up to 16atm which restored antegrade flow. There was a question of whether there maybe was a dissection in the prox lad also. The thrombosis was treated by wiring and performing manual thrombectomy using an export catheter to remove the suspected thrombosis along with balloon dilation. The aspiration catheter was placed distally after there was difficulty negotiating the bend. Timi 3 flow looked improved after aspiration but then there was a concern about the terminal left main and origin of the lcx. A large thrombus burden migrated into the circumflex vessel upon removal of the export cath with no flow of entire left system causing ischemia and left main significantly compromising flow into the lad and circumflex. The patient developed hemodynamic collapse and left main occlusion. An attempt to debulk thrombus from the lad with the aspiration catheter was unsuccessful. A 3. 5 x 18mm resolute onyx stent was implanted in the left main at 12atm. Angiography showed no improvement with the left main remaining closed. Further aspiration attempt of the stented area into the terminal lad was unsuccessful. Further balloon angioplasty was unsuccessful. Three euphora balloon catheters in total were used during the procedure. Ef was 5% and the patient was placed on emco. Upon removal of the export cath with no flow of entire left system causing ischemia. The patient was transferred to another facility where patient death occurred on the same day. The physician who performed the initial pci stated the onyx stent was not the cause of death. The physician assessed that medtronic products were not the cause of death, not the stent, not the balloon, not the aspiration catheter. The patient was on dapt at time of the event.
Manufacturer Narrative
Image analysis summary: two sets of images were provided. The images provided from the procedure on (b)(6) 2018 capture a contrast image showing the lesion in the proximal lad as reported by the account. The tortuous nature of the lesion is visible and patchy regions of contrast along the lesion are suggestive of calcification. A stent is then delivered to the lesion and is deployed but does not fully expand. A dent like appearance in the stent indicates a lesser expanded region. Following placement of the stent there appears to be improved flow in the vessel as shown by the flow of contrast. A balloon device is then inflated within the stent. This could possibly be the post dilation 2. 0 x 15mm sprinter otw balloon but this cannot be confirmed. A final angiogram of the initial procedure shows the treated lesion which appears to have improved flow as shown by the path of contrast in the vessel. The second set of images provided from the account capture the procedure on (b)(6) 2018. A contrast image shows an occluded left main and proximal lad. A negative contrast image shows an abrupt discontinued path of contrast where the previously deployed stent in the lad was placed, suggestive of the reported thrombus. A balloon is delivered to the occluded vessel and dilation is performed. Further dilations of the occluded region are performed. A contrast image shows no flow in the lad or lcx suggesting that the lcx was also occluded. A balloon is delivered into the previously deployed stent and expanded. Further dilations performed, and the balloon is delivered to the distal end of the stent and inflated. A final image shows no flow in the lad. There were no images showing the use of the export aspiration catheter. A dissection was not visible in the images. Malapposition could not be verified from the images. If information is provided in the future, a supplemental report will be issued.
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Manufacturer (Section D)
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key8347511
MDR Text Key136443685
Report Number9612164-2019-00540
Device Sequence Number1
Product Code LOX
UDI-Device Identifier00643169560024
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/06/2020
Device Model NumberEUP2515X
Device Catalogue NumberEUP2515X
Device Lot Number215039098
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2018
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: 02/18/2019 Patient Sequence Number: 1