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

Catalog Number SLC3020X

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Occlusion (1984); Shock (2072)

Event Date 06/18/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

An attempt was made to use one solarice rx ptca balloon catheter to treat a moderately tortuous and calcified lesion located in the proximal left main/ left anterior descending artery.The device was inspected with no issues noted.The lesion was pre dilated once at 10 atm.The solarice was used with a launcher guide catheter and non-medtronic guide wire.The device did not pass through a previously deployed stent.Resistance was not encountered and excessive force was not used during delivery.During the first inflation (10 atm) it was observed that there was a delay of about 4-5 seconds until the balloon opened.Following inflation balloon deflation difficulties occurred, the device would not deflate at the lesion site.The deflation device was removed and reattached, however it was not possible to deflate the balloon.It was informed that the device could not be deflated and this caused an ischemic shock and the patient died.

Manufacturer Narrative

The patient's overall vessel-condition was rather poor and highly calcified.The complete device could not be removed.Only the hub and parts of the shaft were removed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: radial access was taken.The patient had a small left main artery.The right coronary system was very small.The patient had a large left coronary system.The patient was not considered a high risk patient.The procedure was considered not too complex.The solarice device prep went normally, no resistance was noted when prepping.Removal of the sheath and stylette was confirmed to be normal.Contrast media ratio was 18ml contrast, 18ml water, 4ml of nitroglycerin.The non-medtronic inflation device was filled with 10 to 15cc of media at the start of the procedure.The launcher guide catheter was delivered easily, there was no tortuosity or kinking of the guide.The wire passed easily to desired site.The solarice was the first device to be delivered to the lesion.The balloon was left inflated in lm for 2 to 3 seconds.An attempt was made to remove the solarice balloon.There was no movement.The patient had no flow in the rca.A decision was made to attempt to remove the balloon immediately.The solarice hub was cut off.It was intended to advance a non-medtronic guide extension catheter (gec) over the proximal balloon and retract both together, however the attempt did not work.It was reported that the solarice shaft broke.An attempt was made to snare and retract the distal shaft, but the attempt was not successful.An attempt was made to use biopsy forceps to rupture the balloon, but this was unsuccessful.An attempt was made to use a second stiff wire to poke/rupture the balloon, but the balloon could not be ruptured.The original guidewire was in place at all times.The physician assessed that the deflation failure of the solarice balloon contributed to patient death.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review analysis by medical professional: it was a complex pci, with impella support.Multivessel disease and probably hf with dilated and low ef heart.The target lesion was lm/p-lad, calcification and with tortuosity.During pre-dilation, balloon on lad never deflated.Correction: product analysis summary: delivery system, and the distal section of the launcher guide catheter and a non-medtronic guide extension catheter was received for analysis.A kink was evident on the hypotube, tactile testing confirmed kink.There was a detachment on the hypotube 1.7cm distal to the strain relief.Both sides of the detachment site on the hypotube were clean and smooth.There was a detachment on the transitional shaft, 5.4cm of the core wire was exposed.The material at the detached site on the transition shaft was stretched and torn.The remainder of the device did not return for analysis.It was not possible to perform deflation testing due to the condition of the returned delivery system.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: SOLARICE RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8722546
• MDR Text Key: 148794626
• Report Number: 9612164-2019-02478
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2021
• Device Catalogue Number: SLC3020X
• Device Lot Number: 217498818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2019
• 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): Death; Required Intervention
• Patient Age: 74 YR