MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK 8; CORONARY STENT SYSTEM

Catalog Number 1012166-12

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a 2.75 x 12 mm rx multi-link 8 stent delivery system (sds) was selected for the procedure.During preparation (air aspiration) of the sds prior to use, the physician was unable to remove all of the air from the sds indicating that there may be a leak in the balloon.The sds was not used in the procedure.There was no patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported leak.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Manufacturer Narrative

(b)(4).Corrections: device status changed from not returning to returned.Evaluation summary: a visual and functional inspection was performed on the returned device.The reported leak was confirmed.The investigation determined that the reported leak appears to be related to circumstances of the procedure.It should be noted that per the multi-link 8 instructions for use, the device should be prepped (air aspirate) prior to use in the patient.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

The return device analysis noted blood in the guide wire lumen and a tear in the guide wire exit.Follow-up with the account confirmed that the stent delivery system was loaded onto the guide wire and inserted into the patient anatomy.Air aspiration was performed inside the patient anatomy at which time air bubbles were observed in the inflation device.No additional information was provided.

• Brand Name: MULTI-LINK 8
• Type of Device: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6178680
• MDR Text Key: 62698970
• Report Number: 2024168-2016-08915
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 1012166-12
• Device Lot Number: 6042541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 75