MAUDE Adverse Event Report: MEDTRONIC (IRVINE) UNKNOWN SOLITAIRE; CATHETER, THROMBUS RETRIEVER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Perforation (2001); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following adverse event through literature review of ¿effects of intermediate catheter evolution on technical outcome of mechanical thrombectomy¿a comparison of the performance of two distal access catheters in mechanical thrombectomy of acute ischemic stroke¿ solitaire ab/fr revascularization devices were used in >90% of the procedures.Mean age was 68.7 (range, 16 - 97 years).Mt was performed with c1 in 282 patients (70.9%) and with c2 in 116 patients (29.2%).Complications: overall, 13 periprocedural complications occurred with more complications in the c1 group.There were 4 vessel dissections with c1 patients, whereas no dissection was monitored in c2 patients.With c2, there was a vessel perforation in a patient with distal ica occlusion, after 5 stent-retrieval maneuvers with solitaire 4/20.Successful reperfusion in our study was reached in 84.5%, which is in line with the results of recent randomized trials.There was also report of 4 vessel dissections and 2 vessel perforations.However, only one was reported to have been caused by the solitaire.There was also note of 1 case where there was emboli to new territory (ent) and vessel perforation.

• Brand Name: UNKNOWN SOLITAIRE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): MEDTRONIC (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8768513
• MDR Text Key: 150389116
• Report Number: 2029214-2019-00690
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other