MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNK-CNV DCS ORBIT

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

Patient Problem Nerve Damage (1979)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

This is initial/final mdr report being submitted with associated mfr# 3008264254-2017-00087 literature article attached to this report.Brand name unavailable, catalog# unknown, udi unavailable, lot unknown.Concomitant products: microcatheter (excelsior, excel 14 or sl-10; boston scientific, (b)(4)); guglielmi detachable coils (gdc; boston scientific, (b)(4)), cook¿s detachable coils (cdc; cook inc.) neither the catalogue number nor the lot number was available thus neither dhr nor fal could be completed.Palsy, described as neurologic deficits, are known potential adverse event associated with the use of the codman embolic coil devices.Although there is not product specific information available, all products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that the specific target lesion, and pre-existing symptoms of such, may have contributed to the report of palsy.There is no evidence of manufacturing related issues.No further actions are required at this time.

Event Description

In the literature article ¿efficacy of endovascular surgery for unruptured internal carotid artery aneurysms presenting with cranial nerve symptoms¿ by s.Suzuki, a.Kurata, s.Kan, m.Yamada, j.Niki, i.Yuzawa, k.Sato, k.Iwamoto, h.Oka, and k.Fujii, published interventional neuroradiology 13 (suppl 1): 163-169, 2007, it was reported that patient # 17, a (b)(6) female, had temporary worsening of symptoms after implantation of unknown trufil dcs coils.Per the article: ¿whether endovascular surgery is able to reduce the mass effects of unruptured aneurysms is still controversial, although some reports have suggested efficacy in cases of internal carotid artery aneurysms with cranial nerve palsy.Here we assessed outcome in a series of cases.Eighteen patients with un-ruptured internal carotid artery aneurysms presenting with cranial nerve palsy were treated by endovascular surgery.The patients were two males and 16 females aged from 19 to 84 (mean 59.6 years).Aneurysms were located in the cavernous portion in 14, at the origin in one and at the origin of p-com in three.The aneurysms were all embolized using guglielmi detachable coils, interlocking detachable coils, cook¿s detachable coils or trufill dsc and detachable balloons were applied to occlude the proximal parent artery.We analyzed the efficacy of endovascular surgery for such aneurysms retrospectively.The mean aneurysm size was 21.4 mm and the mean follow-up period was 57.7 months.Palsy of iind cranial nerve was evident in three patients, of the iiird in eight, of the vth and vth in one each, and of the vith in nine.Post embolization occlusion was complete in nine patients and neck remnant in the other seven.Regarding complications of endovascular surgery, one case (5.6%) showed tia after embolization.Overall 11 (46%) cranial nerve symptoms showed complete resolution, eight (33%) showed some improvement, and five (21%) were unchanged.In three cases (12.5%), the symptoms worsened after treatment.The shorter the duration of symptoms was a factor predisposing to resolution of symptoms.In complete resolution cases, the timing of treatment after symptoms appeared and the time of complete resolution were in proportion.These results showed that there is no difference in reduction of mass effects between surgical clipping and endovascular surgery for unruptured internal carotid artery aneurysms.With endovascular surgery, the rapidity of treatment after symptoms is the most important factor for successful results.¿ at the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6651119
• MDR Text Key: 77886660
• Report Number: 3008264254-2017-00087
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CNV DCS ORBIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR