MAUDE Adverse Event Report: SEE H.10 COIL-THERMO MECHANICAL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNK COIL-THERMO MECHANICAL

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

Patient Problem Stroke/CVA (1770)

Event Date 03/31/2013

Event Type  Injury  

Manufacturer Narrative

Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Product complaint # (b)(4).

Event Description

This complaint is from a literature source.It was reported that 2 female patients with non-small (>3 mm) aneurysm (from non-small aneurysms group) who underwent balloon-assisted coil embolization, suffered cerebral embolism.Title: efficacy and complications of endovascular embolization for very small (3 mm or smaller) ruptured cerebral aneurysms.The purpose of this study was to analyze an endovascular embolization of very small aneurysms and high risk for aneurysm perforation.Method: initial angiographic results of ruptured aneurysm between under 3 mm in diameter (21 cases in small group) and over 3 mm in diameter (85 cases, non-small group) were compared.From (b)(6) 2010 to (b)(6) 2013, endovascular coil embolization of 106 aneurism in 106 conservative patients with ruptured cerebral aneurism were performed.

• Brand Name: COIL-THERMO MECHANICAL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• Manufacturer (Section G): SEE H.10; 47709 fremont blvd; fremont CA
• Manufacturer Contact: gabriel alfageme ; chemin-blanc 38; le locle neuchatel CH-24-00 ; SZ CH-2400 ; 949789-868
• MDR Report Key: 8270934
• MDR Text Key: 133863817
• Report Number: 2954740-2019-00528
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

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
• Device Catalogue Number: UNK COIL-THERMO MECHANICAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR