MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWBC30
Medical Device Problem Code	Material Torqued (2980)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/20/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional patient codes: (b)(4).Product analysis: the product was discarded by the customer; therefore, no product analysis can be performed.  conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant of a transcatheter bioprosthetic valve, into a heavily calcified bicuspid valve with calcification extending into the left ventricular outflow tract (lvot), the annulus was pre-dilated with a 18mm balloon and a 26mm valve was implanted.A post implant balloon aortic valvuloplasty (bav) was performed and the patient became hypotensive.An echocardiogram indicated a pericardial effusion and cardiac tamponade.A left ventricle perforation caused by the guidewire occurred.It was reported that the guidewire had not been reshaped and had been inspected for any abnormalities prior to introduction into the patient.No resistance had been felt during use, however it had been ¿torqued or twisted¿ due to difficult anatomy and small left ventricle.A pericardiocentesis was performed and medications to support the patient¿s blood pressure were administered.An annular rupture caused by the balloon aortic valvuloplasty (bav) was also confirmed.A laparotomy was performed due to a distended abdomen and confirmed a liver laceration due to a diagnostic catheter.A surgical repair of both the liver and annulus was performed, however the patient expired four days later.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Conclusion: the physician found that the confida guidewire had not been preshaped prior to usage, however, the physician did state that he had torqued or twisted the guide wire as the patient had a very difficult and small left ventricle.So the perforation most likely occurred as a result of the user having difficulty accessing the patients anatomy paired with pushing/ torquing or twisting the guide wire in the process.Angiographic record review was conducted on the returned angios for this event, however, there was no evidence of the wire causing the perforation in the imaging provided.Also, there was no evidence of the tamponade, hypotension or effusion on the images provided.The lot history review was performed on the guidewire, by the supplier; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The confida instructions for use (ifu) cautions the user to not manipulate the device without fluoroscopic visualization, in addition, the ifu warns the user to not torque the guidewire, do not push, pull or rotate the wire against resistance.In addition, cardiac perforation, effusion, tamponade and hypotension (hypovolemia) are known potential patient adverse effect per the ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.This event does not indicate device misuse or malfunction.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7129812
• Report Number: 2025587-2017-02496
• Device Sequence Number: 16653397
• Product Code: DQX
• UDI-Device Identifier: 20643169583737
• UDI-Public: 20643169583737
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K132623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 91605633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 12/19/2017; 05/30/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 12/19/2017; 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Weight: 35