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

Catalog Number 1012165-28

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a proximal and first diagonal of the left anterior descending artery.A 2.75 x 38 mm multi-link 8 was deployed.A 2.5 x 28 mm multi-link 8 was advanced to the lesion; however, negative was pulled before inflating and blood came into the inflation device.The device was removed and exchanged for another 2.5 x 28 multi-link 8 when the stent struts flared possibly due to interaction with the implanted 2.75 x 38 multi-link 8.A non-abbott stent was implanted with the mini crush technique to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4) - incorrect prep.Evaluation summary: the device was returned for evaluation.The leak was confirmed.Based on visual and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the complaint handling database revealed no other incidents for leaks reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Additionally, it should be noted the multi-link 8 coronary stent system (css), instructions for use (ifu) states: prepare an inflation device/syringe with diluted contrast medium.Attach an inflation device/syringe to the stopcock; attach it to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device/syringe of all air.Repeat steps until all air is expelled.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4466312
• MDR Text Key: 5320704
• Report Number: 2024168-2015-00471
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P020047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 1012165-28
• Device Lot Number: 3011641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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
• Treatment: STENT: MULTI-LINK 8 2.75X38MM