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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 6X25; CATHETER, THROMBUS RETRIEVER
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CONCENTRIC MEDICAL TREVO XP PROVUE RETRIEVER 6X25; CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number 90186
Device Problems Break (1069); Component Missing (2306)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative
Subject device is not available.
 
Event Description
It was reported that mechanical thrombectomy was performed to treat a basilar artery occlusion and recanalization of the vessel was confirmed.The physician encountered resistance when withdrawing the retriever (subject device) from the patient¿s vessel and the retriever distal marker broke and was left in the patient¿s vessel.Post procedure computer tomography (ct) scan confirmed the distal marker in the distal part of the posterior cerebral artery of the patient.There were no clinical consequences to the patient.
 
Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the trevo provue core wire was found cut approximate 1.5cm distal to the stent proximal.The shaft was also found cut.The core wire appeared to be cut with a sharp object.The core wire proximal section and shaft coil were not returned.The trevo provue stent was returned and no anomalies was noted with the struts.No sign of stretching was noted.The trevo provue platinum markers were examined under magnification and all three platinum markers were present.The hydrophilic coating was also examined and no anomalies was observed.Due to the nature of the complaint, functional testing was not performed.The reported complaint for the trevo distal maker missing from the stent was not confirmed.All three of the platinum markers were present on the trevo provue distal end.Based on the additional information provided by the customer, resistance was encountered when advancing the retriever into the lesion and during removal of the device from the patient¿s anatomy; therefore, procedural factor was assigned to the as reported complaints of 'nv - un-retrieved device fragments' and 'nv - difficult/unable to withdraw retriever' and for as analyzed analyzed 'nv - retriever fracture/broken ¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural factor during use, the device performance was limited.
 
Event Description
It was reported that mechanical thrombectomy was performed to treat a basilar artery occlusion and recanalization of the vessel was confirmed.The physician encountered resistance when withdrawing the retriever (subject device) from the patient¿s vessel and the retriever distal marker broke and was left in the patient¿s vessel.Post procedure computer tomography (ct) scan confirmed the distal marker in the distal part of the posterior cerebral artery of the patient.There were no clinical consequences to the patient.
 
Manufacturer Narrative
H6: device code grid - corrected.H6: result code grid ¿ corrected.H6: conclusion code grid ¿ corrected.The initial as reported issue retriever fracture/broken was replaced with ro marker(s) detached/separated/not visible under fluoroscopy to capture the reported issue appropriately.A cause code of not confirmed has been assigned to the as reported issue ro marker(s) detached/separated/not visible under fluoroscopy as the markers were confirmed during analysis to be present.
 
Event Description
It was reported that mechanical thrombectomy was performed to treat a basilar artery occlusion and recanalization of the vessel was confirmed.The physician encountered resistance when withdrawing the retriever (subject device) from the patient¿s vessel and the retriever distal marker broke and was left in the patient¿s vessel.Post procedure computer tomography (ct) scan confirmed the distal marker in the distal part of the posterior cerebral artery of the patient.There were no clinical consequences to the patient.
 
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Brand Name
TREVO XP PROVUE RETRIEVER 6X25
Type of Device
CATHETER, THROMBUS RETRIEVER
Manufacturer (Section D)
CONCENTRIC MEDICAL
301 east evelyn
mountain view CA 94041
MDR Report Key7515323
MDR Text Key108292832
Report Number0002954917-2018-00048
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00815742001860
UDI-Public(01)00815742001860(17)180628(10)60304
Combination Product (y/n)N
PMA/PMN Number
K143077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2018
Device Model Number90186
Device Catalogue Number90186
Device Lot Number60304
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Date Manufacturer Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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