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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number UNK_NEU
Device Problem No Apparent Adverse Event (3189)
Patient Problems Inflammation (1932); No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Subject device remains implanted.
 
Event Description
It was reported that a patient had contrast gathering lesions after aneurysm treatment at the anterior communicating artery (acom), with the subject 6 coils.Non-stryker coil and non-stryker stent were also implanted at the aneurysm location.It was discovered during magnetic resonance imaging (mri) 1 day post-procedure.The patient was not symptomatic post-procedure and at the 3 month-follow-up biopsy was done and result was positive for granulomatous inflammatory response.According to the physician, the contrast gathering lesions are in the treated territories.It is not know if the contrast gathering and the granulomatous inflammatory response are related to the implanted coils mass.No additional information is available at this time.
 
Manufacturer Narrative
Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned.The device was intended to be used for treatment.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information provided by the customer indicated that the device was confirmed to be in good condition after unpacking and preparation and was prepared as per the dfu.It was reported that 1 day-post procedure post-procedure, mri imaging showed contrast gathering lesions (a few micro infarct lesions) in the treated territories.The patient was not symptomatic post-procedure and at the (b)(4) month-follow-up, biopsy was done, and result was positive for granulomatous inflammatory response.The complaint allegation was possibly against the coil mass.Based upon medical review assessment, the data reasonably suggest the clinical event is anticipated in nature and severity as per the dfu.Therefore, an assignable cause of anticipated procedural complication will be assigned to the as reported.
 
Event Description
It was reported that a patient had contrast gathering lesions after aneurysm treatment at the anterior communicating artery (acom), with the subject (b)(4) coils.Non-stryker coil and non-stryker stent were also implanted at the aneurysm location.It was discovered during magnetic resonance imaging (mri) (b)(4) day post-procedure.The patient was not symptomatic post-procedure and at the (b)(4) month-follow-up.Biopsy was done and result was positive for granulomatous inflammatory response.According to the physician, the contrast gathering lesions are in the treated territories.It is not know if the contrast gathering and the granulomatous inflammatory response are related to the implanted coils mass.No additional information is available at this time.
 
Manufacturer Narrative
B1, b2, h1: not applicable.B5: executive summary: corrected: additional information received on (b)(6)2020 clarified that the granulomatous inflammatory response was not related to the subject coil mass.H6 patient code: corrected: no consequences or impact to the patient after reviewing the additional information received on (b)(6)2020 , the granulomatous inflammatory response was not related to the subject coils.The patient was asymptomatic.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.
 
Event Description
It was reported that a patient had contrast gathering lesions after aneurysm treatment at the anterior communicating artery (acom), with the subject (b)(4) coils.Non-stryker coil and non-stryker stent were also implanted at the aneurysm location.It was discovered during magnetic resonance imaging (mri) (b)(4) day post-procedure.The patient was not symptomatic post-procedure and at the (b)(4) month-follow-up.Biopsy was done and result was positive for granulomatous inflammatory response.According to the physician, the contrast gathering lesions are in the treated territories.It is not know if the contrast gathering and the granulomatous inflammatory response are related to the implanted coils mass.No additional information is available at this time.Additional information received on (b)(6)2020 clarified that the granulomatous inflammatory response was not related to the subject coil mass.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9728809
MDR Text Key180199829
Report Number3008881809-2020-00045
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Was Device Available for Evaluation? No
Date Manufacturer Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LVIS STENT (MICRO VENTION INC.); MICRUSFRAME C-14 (CODMAN); SOLITAIRE STENT (MEDTRONIC); TARGET COILS (STRYKER)
Patient Outcome(s) Other;
Patient Age34 YR
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