MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number	EUP2520X
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Codes	Intimal Dissection (1333); Patient Problem/Medical Problem (2688)
Date of Event	06/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use euphora rx balloon catheter to treat a lesion in the lcx.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.There was some difficulty experienced when removing the protective sheath/packaging stylette from the device but the stylette was removed.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.No resistance encountered when advancing the device.No excessive force used during delivery.No difficulties were noted during inflation of the device.It was reported that there were balloon deflation difficulties were encountered.The device would not deflate at the lesion site.50%/50% concentration of contrast/saline were used by the physician.The issue occurred on the first inflation.The physician inflated the balloon to 23 atm to burst the balloon so they could remove it.The ruptured balloon caused a dissection which was treated with two stents.The physician completed the procedure with euphora 2.5 x 20 rx (212633097).The physician stated that the lesion was heavily calcified which may have caused an issue with the balloon and that there was a cleft of calcium at the lesion site.Patient is alive.
Additional Manufacturer Narrative
Additional information: the euphora rx balloon catheter was intended to be used to treat a lesion in the rca.There was a thrombus/tight 95% lesion in the mid right coronary artery.The rca was tortuous and calcified.When the deflation difficulty occurred, the physician inflated the balloon to about 18 atm which popped the balloon proximally, so they could remove it.It was reported that there was some calcification that damaged the balloon and caused a little dissection proximally, but no rupture of the artery.The physician decided to stent the most distal portion of the lesion.A 2.5 x 26mm resolute integrity drug eluting stent was deployed at 14 atm.Then a 3.0 x 26mm resolute integrity drug eluting stent was deployed at 16 atm, with excellent result.The 1 rv marginal branch was jailed, but there was no difference to the flow in the branch, and the branch was left wide open.There was no evidence of any real complications due to stent implantation.It is reported that the ruptured balloon did not seem to make any clinical difference in the long run.Evaluation summary: the stylette did not return in the device.Proximal balloon bond stretched.A section of the inflation lumen surrounding the balloon bond had been inflated and had burst.A longitudinal tear was evident along the inflation site.The inflation lumen material was jagged and uneven at the tear site.Distal tip stretched and deformed.The balloon could not be inflated due to the burst on the inflation lumen.Image review the images capture a coronary angiogram (cag) of the left coronary system showing a cto of the proximal lcx.No treatment was captured on the images for this vessel.A lesion site is visible in the rca.The attempted delivery and inflation of the euphora 2.5x20mm device is evident.A section of the inflation lumen proximal to the proximal inner shaft marker is inflated; most likely the proximal balloon bond.A dissection is then visible proximal to the site of the balloon inflation.There are no images capturing the reported burst or removal of the euphora balloon.Two unidentified stents are then deployed at the site of the dissection.The dissection is then resolved.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 6700134
• Report Number: 9612164-2017-00866
• Device Sequence Number: 19106391
• Product Code: LOX
• UDI-Device Identifier: 00643169560031
• UDI-Public: 00643169560031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2019
• Device Catalogue Number: EUP2520X
• Device Lot Number: 212633097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017; 09/20/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 08/08/2017; 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-3136-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 65