MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE¿ REVASCULARIZATION DEVICE; CATHETER, THROMBUS RETRIEVER

Model Number UNK-NV-SOLITAIRE

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

Patient Problem Intimal Dissection (1333)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.The event could not be confirmed, as cause could not be definitively determined.The author did not state was caused vessel injury that lead to the re-occlusion or if additional medical treatment was provided.The other 2 patients with the re-occlusion were reported to have been caused by additional thrombus.There is no allegation that the device caused or contributed these events.

Event Description

Medtronic received report through literature review: 535.Delayed reocclusion of recanalized intracranial arteries after mechanical thrombectomy in acute stroke patients.Ks jang, dk jang, sk park, ym han, bh moon and ys park.180 patients were reported to have undergone mechanical thrombectomy with solitaire fr.3 of 163 were reported to have reocclusion of the vessel (there was no reference regarding the 17 other patients).Two of whom had occlusion of mca, and one had occlusion of petrous ica.Per the author, it was suspected that the reason for re-occlusion was dissection of occluded vessel in one patient and the thrombosis of remained thrombus (tici2a, 2b) in the 2 other patients.Initial nihss (national institute of health stroke scale) score were 21, 5 and 15, respectively and nihss score at discharge were 17, 4 and 15, respectively.For all 3 patients, tici grade were 2b, 2b and 2a after the first mechanical thrombectomy.Follow-up angiogram showed complete reocclusion with tici grade 0.And final tici grade were 2a, 2b and 2b, respectively.All three patients had concomitant pta with balloon catheter.Delayed reocclusion of recanalized vessels was noted within 24 hours after first mechanical thrombectomy.

• Brand Name: SOLITAIRE¿ REVASCULARIZATION DEVICE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 5782530
• MDR Text Key: 49175910
• Report Number: 2029214-2016-00546
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-SOLITAIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• 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