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

Catalog Number 1012165-12

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2014

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a critical stenosis in the circumflex artery.After predilatation with an unspecified 1.5x20 mm ballooon catheteter, a 2.5x12 mm multi-link 8 rx (ml8) stent system was advanced toward the target lesion.The ml8 was inflated but unable to reach an adequate balloon inflation pressure, which resulted in a partially deployed stent that was not fully apposed to the vessel wall.No pinholes were identified but a leak in the balloon lumen was suspected.The balloon was deflated and stent system was removed.A new unspecified nc balloon catheter was used to successfully appose the stent to the vessel wall.There was no adverse patient effect.There was clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional reported information indicates that it is unknown if the 2.5x12 mm multi-link 8 stent system was prepped outside of the patient anatomy before use because the physician does not recall the specifics of this case.Additionally, there was no report of leaks or other issues during preparation.No additional information has been provided.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned and the reported inflation issue and leak were 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.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

• 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: 4521130
• MDR Text Key: 5404709
• Report Number: 2024168-2015-00831
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 1012165-12
• Device Lot Number: 4052141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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 Outcome(s): Required Intervention