MAUDE Adverse Event Report: CONCENTRIC MEDICAL UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); No Consequences Or Impact To Patient (2199)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

This is 2 of 2 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), the emboli had traveled from m2 (frontal) to m2 (parietal) and medical intervention was performed to treat the patient¿s ent (emboli to new territory).The procedure was successfully completed.The patient was assessed having a thrombolysis in cerebral infarction (tici) score of 2a before ent treatment and tici score of 3 after ent treatment.Patient status is at home during 90-day visit (90 days after the treatment).Patient¿s mrs (modified rankin scale) score was 3 (moderate disability, require some help but able to walk without assistance of another individual).The score was consistently same since patient¿s discharge.

Manufacturer Narrative

Based on the information received from medical safety on 07-nov-2019 stated that the balloon (bgc) catheter is to arrest the proximal flow and placed in cervical ica.The target occlusion was in right m1 and ent was in different branch of m2 and not allegation against balloon (bgc) catheter.There was no clinical consequence due to this event;therefore, this event no longer meets reporting requirement the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), the emboli had traveled from m2 (frontal) to m2 (parietal) and medical intervention was performed to treat the patient¿s ent (emboli to new territory).The procedure was successfully completed.The patient was assessed having a thrombolysis in cerebral infarction (tici) score of 2a before ent treatment and tici score of 3 after ent treatment.Patient status is at home during 90-day visit (90 days after the treatment).Patient¿s mrs (modified rankin scale) score was 3 (moderate disability, require some help but able to walk without assistance of another individual).The score was consistently same since patient¿s discharge.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), the emboli had traveled from m2 (frontal) to m2 (parietal) and medical intervention was performed to treat the patient¿s ent (emboli to new territory).The procedure was successfully completed.The patient was assessed having a thrombolysis in cerebral infarction (tici) score of 2a before ent treatment and tici score of 3 after ent treatment.Patient status is at home during 90-day visit (90 days after the treatment).Patient¿s mrs (modified rankin scale) score was 3 (moderate disability, require some help but able to walk without assistance of another individual).The score was consistently same since patient¿s discharge.

Manufacturer Narrative

Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 patient embolus is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 9205782
• MDR Text Key: 168892194
• Report Number: 0002954917-2019-00009
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREVO XP PROVUE RETRIEVER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 89 YR