FDA Adverse Event Injury Summary report: N

COIL-THERMO MECHANICAL

MDR report key: 8270977 · Received January 23, 2019

Report

Report Number: 2954740-2019-00527
Event Type: Injury
Date Received: January 23, 2019
Date of Event: March 31, 2013
Report Date: January 3, 2019
Manufacturer: SEE H.10
Product Code: KRD
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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).

Description of Event or Problem · 1

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 A CEREBRAL ANEURYSMS PERFORATION. 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 APRIL 2010 TO MARCH 2013, ENDOVASCULAR COIL EMBOLIZATION OF 106 "ANEURISM" IN 106 CONSERVATIVE PATIENTS WITH RUPTURED CEREBRAL ANEURISM WERE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
64896	COIL-THERMO MECHANICAL	NEUROVASCULAR EMBOLIZATION DEVICE	KRD	SEE H.10

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Life Threatening