MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.5MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412560
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a ruptured anterior communicating artery aneurysm balloon assisted coiling procedure, the subject coil appeared to be stable during initial coiling and on final angiogram following the treatment.Physician performed a computed tomography hours after treatment and subject coil tail was found protruding from the aneurysm into the a1.A second balloon assisted coil procedure was done to secure the aneurysm.The patient is in critical condition due to pulmonary issues.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.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 physician reported that significant amount of coil tail protrudes from the aneurysm (after completion of the procedure).There were no reported issues during delivery, placement or detachment and there is no allegation of a device malfunction.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of "undeterminable" was assigned to as reported "main coil protrusion".
Event or Problem Description
It was reported that during a ruptured anterior communicating artery aneurysm balloon assisted coiling procedure, the subject coil appeared to be stable during initial coiling and on final angiogram following the treatment.Physician performed a computed tomography hours after treatment and subject coil tail was found protruding from the aneurysm into the a1.A second balloon assisted coil procedure was done to secure the aneurysm.The patient is in critical condition due to pulmonary issues.

• Brand Name: TARGET TETRA 2.5MM X 6.0CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19140214
• Report Number: 3008881809-2024-00174
• Device Sequence Number: 18501296
• Product Code: HCG
• UDI-Device Identifier: 07613327578638
• UDI-Public: 07613327578638
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K222533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TG5412560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFORM SUPER COMPLIANT (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown