MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC REVIVE - THROMBECTOMY DEVICE; MICRUS THROMBECTOMY

Model Number N/A

Device Problem Inability to Irrigate (1337)

Patient Problems Death (1802); Vascular System (Circulation), Impaired (2572); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

The complaint devices were unavailable for analysis and no sterile lot numbers were reported thus no fal or dhr could be performed.Arterial dissection, thromboembolic occlusion of a previously unaffected artery resulting, vasospasm, and device ineffective resulting in death are all known potential adverse events associated with eh use of the revive se device and are listed in the ifu as such.There is no evidence of manufacturing issues related to these events and all products undergo a 100% inspection prior to being released for sale to the customers.Review of the available information suggests that parent vessel anatomy, aneurysm characteristics, intraprocedural issues and medication regimen factors may have contributed to these reported events.

Event Description

The literature article "mechanical thrombectomy with stent retrievers in acute basilar artery occlusion" by m.Mohlenbruch, s.Stampfl, l.Behrens, c.Herweh, s.Rohde, m.Bendszus, c.Hametner, s.Nagel, p.A.Ringleb, and m.Pham, published in american journal of neuroradiology, 35:959-64, may 2014, reported that after use of the revive se device patients suffered arterial dissection, thromboembolic occlusion of a previously unaffected artery resulting, vasospasm, and device ineffective resulting in death.There was no patient specific information reported, i.E.Age or sex, the only identifying information provided was the study number assigned to each patient.Between december 2009 and may 2012, endovascular therapy was performed on 31 patients for basilar artery occlusion (bao).Of these, 7 patients were excluded because of endovascular treatment technique with either exclusive local intra-arterial thrombolysis or primary stent placement for high-grade basilar artery or distal vertebral artery stenosis.Twenty-four patients (17 male, 7 female; median age, 70; range, 33-83 years) underwent mt.Nine patients were treated with a competitor's device, 12 patients with revive se, and 2 patients with both devices.The median number of passes for the competitor's device or revive se was 2 (range, 1-10).In 1 of the 2 patients in which both devices (the competitor's device after revive se) were used, successful recanalization was achieved only after the use of a slightly oversized competitor's device (6 mm in diameter) because the diameter of the basilar artery was very large, measuring nearly 5 mm.In the other patient, the basilar artery remained occluded despite 5 attempts with revive se, another 5 attempts with the competitor's device, and even after eventual percutaneous transluminal angioplasty.Patient #11 experienced vasospasm after the device was used.This was treated with anti-spasmolytic medications successfully.Patient #12 suffered thromboembolic occlusion of a previously unaffected artery resulting in death.Patient #13 suffered arterial dissection of the vertebral artery in segment 2, treated successfully with permanent stent implantation.Patient #15 suffered arterial dissection of the vertebral artery in segment 1, treated successfully with permanent stent implantation.Patient #17 suffered thromboembolic occlusion of a previously unaffected artery successfully treated with thrombolytic medications.For patient #18 the device was ineffective and arterial dissection was noted.Both were treated successfully.Patient #22 suffered vasospasm that was successfully treated with anti-spasmolytic medications.For patient #23 both the revive and the competitor's device were ineffective and the patient subsequently died.No sterile lot numbers were reported and none of the devices are available for analysis.

• Brand Name: REVIVE - THROMBECTOMY DEVICE
• Type of Device: MICRUS THROMBECTOMY
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5089777396
• MDR Report Key: 5051860
• MDR Text Key: 24981283
• Report Number: 2954740-2015-00202
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKREVIVESE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention