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Model Number PED-475-35
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Infarction, Cerebral (1771)
Event Date 01/15/2018
Event Type  Injury  
Manufacturer Narrative
Device returned. Device evaluation: the pipeline flex delivery system was returned for evaluation with the catheter and guide catheter. As received, a minimal amount of blood was observed on the devices. The pipeline flex braid was not returned as it was implanted in the patient. The pipeline flex re-sheathing pad appeared to be damaged. The distal hypotube was found severely stretched. Approximately 3. 5 cm of the distal segment of the tubing jacket was found to be torn and missing from the hypotube. The remaining tubing jacket was found to be peeled off from the hypotube for the length of approximately 24 cm. The pushwire was found to be bent at a section near the proximal end. Based on the analysis findings, the reports of intraprocedural resistance was confirmed. In addition, the ptfe heat shrink jacket was found stretched and peeled off from the pipeline flex pushwire. It is possible that the patient¿s severe vessel tortuosity may have contributed to the resistance during delivery, subsequently causing the devices to become damaged. From the damages observed during analysis, it appears that excessive force was used (pushing and pulling). In areas that the laser-cut hypotube of the pipeline flex pushwire was stretched, the resultant decrease in hypotube outer diameter (od) led to a loosening of the ptfe heat shrink jacket. The locations on the hypotube most severely damaged by stretching correspond to the areas of significant damage to the ptfe jacket. The root cause is believed to be the application of excessive force when delivering the ped, causing damage to the body of the catheter and lumen of the guide catheter. The damage subsequently caused an increased frictional force when retrieving the pipeline flex delivery system leading to a stretched hypotube, which stripped the ptfe heat shrink off of the stretched sections of hypotube. Our instructions for use (ifu) provides the following guidance: ¿never advance or withdraw an intraluminal 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. ¿ the lot history records of the reported lot numbers showed no quality issues and no other anomalies were found during the document review. No evidence was found to suggest that the device failed to meet specifications; manufacturing has been ruled out as a potential cause. All products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
The pipeline flex braid will not be returned for evaluation as it was implanted in the patient. It was not reported whether the pipeline flex delivery system will be returned. 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. If information is provided in the future, a supplemental report will be issued.
Event Description
Medtronic received report of infarction after pipeline flex placement. It was reported that the pipeline flex was placed in the treatment of an unruptured, cerebral aneurysm (15 mm). After placement, an angiographic image was taken which showed infarction at the distal m2. The physician reportedly assumed "ent due to thrombus. " the physician attempted suctioning and administration of t-pa, which did not resolve the issue. A stent device was then used for mechanical thrombectomy. Upon removal of the stent, the physician noticed it had removed a "white and long material" from the patient. The physician commented that the material was not a substance that could have originated from the human body and alleged that the substance was an artifact. The physician describes the material as "semitransparent and vinyl-polymer-like"; the length was slightly less than 1 cm and width was approximately 2 mm. It was reported that the patient had not experienced any adverse issues since the procedure.
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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 Key7263703
MDR Text Key110284303
Report Number2029214-2018-00097
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2019
Device Model NumberPED-475-35
Device Lot NumberA307609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2016
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: 02/12/2018 Patient Sequence Number: 1