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

Catalog Number NCSLC2527X

Device Problem Difficult to Remove (1528)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: kinks were evident along the hypotube.The balloon returned deflated with crystallized residue present inside the balloon.There was deformation to the distal tip.A 0.015 inch mandrel could not be loaded through the inner lumen due to slight stretching on the distal shaft.Kinks were evident along the distal shaft.

Event Description

The physician was attempting to treat a severely calcified rca lesion, 99% stenosis and medium tortuosity.It was reported that the patient initially underwent rotablation with 2 different drills followed with subsequent pre-dilatation of target lesion using 2 x solarice rx balloons inflated to 14atm.The physician proceeded to implant 3 x resolute integrity stents.In stent re-stenosis was reported.Approximately 80% was observed, localized in the same vessel but, more distal, was not treated during that procedure.Small resistance was encountered especially during removal but was successful in removing devices.Seven x nc solarice balloons were used for post-dilation inflated to 20atm and passed through the previously implanted stents.No issues were reported removing the protective sheath / stylet during device prep of any of the balloons used.The devices were inspected prior to use with no issues noted.Issues were experienced when delivering all the balloons to the target lesion due to the heavy calcification.During inflation of all balloons used, the operator believes that the balloons were not opened completely due to the strong calcification.No issues reported during deflation of the balloons used.Enough time was given to allow the balloons to deflate following inflation.It was reported that removal difficulties following balloon inflation was reported for all 9 balloons used.Removal difficulties were experienced with other devices after wires were replaced.In one instance the non-mdt wire used had to be removed along with one of the balloons (operator unsure which one) because withdrawal of the balloon was not possible.Resistance was encountered when removing the remaining balloons reported.The physician commented that the procedure was very tough and performed in very difficult conditions.It was reported that the patient died several days after the procedure.The physician reported that in his opinion the use of the balloons and subsequent removal difficulties were not related to cause of death.The physician does not believe that the death was related to the implanted stents.Autopsy to be performed.

Manufacturer Narrative

Fdp code corrected.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.

Manufacturer Narrative

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

Manufacturer Narrative

Image review: review of the procedural images confirmed the narrow and severely calcified nature of the rca.Numerous pre-dilations and rotablations were performed prior to deployment of three stents along the rca.Numerous post-dilations were performed.The images do not capture the removal difficulties reported by the account.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC 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: 6613742
• MDR Text Key: 76738672
• Report Number: 9612164-2017-00653
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K141090
• 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
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2018
• Device Catalogue Number: NCSLC2527X
• Device Lot Number: 212420679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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 Age: 58 YR