MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE RETRIEVER 4X20; CATHETER, THROMBUS RETRIEVER

Catalog Number	90182
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: subject device is not available.
Event or Problem Description
It was reported that the subject stent retriever was delivered to the lesion in the middle cerebral artery (mca) for endovascular ischemic stroke thrombectomy case.After the clot was captured, the physician pulled back the delivery wire assuming the subject stent would follow as well; however, the subject stent was left inside the right mca reaching out from internal carotid artery (ica) distal as it broken off from the delivery wire.Another device was used to complete the procedure.The patient was doing good for the first two days after the procedure, then his condition worsened.The physician believes that the patient is now right hemiplegic due to the broken stent retriever.
Event or Problem Description
It was reported that the subject stent retriever was delivered to the lesion in the middle cerebral artery (mca) for endovascular ischemic stroke thrombectomy case.After the clot was captured, the physician pulled back the delivery wire assuming the subject stent would follow as well; however, the subject stent was left inside the right mca reaching out from internal carotid artery (ica) distal as it broken off from the delivery wire.Another device was used to complete the procedure.The patient was doing good for the first two days after the procedure, then his condition worsened.The physician believes that the patient is now right hemiplegic due to the broken stent retriever.
Additional 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 retriever core wire had been separated on its distal section.The trevo provue core wire was approximately 177.5cm section was returned from its proximal end.The core wire distal separated section and retriever were not returned.Functional testing could not be performed due to the condition of the returned device.From the condition of the product it appears that the product had been under excessive manipulation.In case of this complaint, while there are a number of potential causes for the reported issue, because review and analysis of available information to identify a definitive cause, a cause of undetermined was assigned to the as reported issues retriever fracture/broken inside patient and un-retrieved device fragments.An assignable cause of anticipated procedural complication was assigned to the reported issue patient complication, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the direction for use (dfu), product labeling and/or risk documentation files.D4: expiration date: added d10/h3: product available to stryker: updated h4: manufacturing date: added h3: device evaluated by mfg: updated.

• Brand Name: TREVO XP PROVUE RETRIEVER 4X20
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8624748
• Report Number: 3012931345-2019-00047
• Device Sequence Number: 2260417
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (Y/N): N
• PMA/510(K) Number: K132641
• 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): 07/10/2019

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 Expiration Date: 08/27/2020
• Device Catalogue Number: 90182
• Device Lot Number: 0000014000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 75