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Model Number PED-475-18
Device Problems Difficult To Position (1467); Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex with shield has not been returned for evaluation. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. Suspect medical device brand name: pipeline flex with shield technology model number: ped2-475-18 mdrs related to this event: 2029214-2018-00120, 2029214-2018-00121, 2029214-2018-00122. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received report that a pipeline flex with shield did not open during a procedure. The patient was undergoing flow diversion treatment of an unruptured, amorphous aneurysm in the left internal carotid artery (ica). The aneurysm had a max. Diameter of 13. 4mm and neck diameter of 3mm. The landing zone artery size was 4. 73mm distal and 4. 72mm proximal. Vessel tortuosity was described as moderate. A continuous heparinized saline flush was used during the procedure. A pipeline flex with shield was attempted to be placed. At deployment, it was reported that there was a delay in the distal end of the pipeline flex with shield braid opening. The device was resheathed and re-deployed; full opening of the braid was observed. However, during continued deployment of the braid, the device became stuck in the catheter. The pipeline flex with shield was unable to be pushed forward or pulled back. The braid slipped from its intended location and was subsequently removed with the catheter. Ultimately, the procedure was completed by aneurysm coiling. There were no reports of patient injury in association with this event.
Manufacturer Narrative
Device evaluation: the pipeline flex with shield was returned for evaluation. As received, the pipeline flex with shield was stuck at the distal segment of the catheter. The pipeline flex with shield could not be pushed forward or removed. For further examination, the catheter was cut to remove the pipeline flex with shield. The pipeline flex with shield distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The pushwire appeared to be bent near the proximal end. The distal and proximal ends of the pipeline flex shield braid were found fully opened with moderate fraying. Based on the analysis findings, the report of pipeline flex with shield failure to open could not be confirmed ¿ the returned pipeline flex with shield braid were found fully open. It is possible that the patient¿s moderate vessel tortuosity contributed to the reported issues. Additionally, from the damage observed on the returned products, it appears that excessive force was used. It is likely the damage observed during analysis occurred when the pipeline flex devices were advanced/retrieved against resistance. Our instructions for use (ifu) provides the following guidance: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. ¿ all products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key7282953
MDR Text Key100664884
Report Number2029214-2018-00121
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/03/2020
Device Model NumberPED-475-18
Device Lot NumberA439489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial