MAUDE Adverse Event Report: ABBOTT VASCULAR MULTI-LINK 8; CORONARY STENT DELIVERY SYSTEM

Catalog Number 1012165-38

Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an 80% stenosed, mildly tortuous vessel without calcification in the left circumflex (lcx) artery involving a bifurcation.The physician was planning to place 3 stents using the culotte technique and was planning to deploy one stent for culotte and the other to the proximal.However, when trying to re-cross the lesion where the 2.5x38mm multi-link stent was implanted (inflated once at 16 atmospheres (atms) for 30 seconds), the guidewire became tangled with the stent struts.Post dilatation was performed using a non-abbott balloon at 20-22 atms for 30 seconds.The physician put down another non-abbott balloon to the site where the guidewire was stuck and tried to use the balloon as an anchor.The physician failed to retrieve the guidewire and dragged out the entire stent.The stent was damaged and noted to be flared when it was explanted.Another stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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 similar incidents from this lot.The physician was trying to re-cross the lesion distal to where a multi-link 8 stent was previously implanted.It should be noted that the multi-link 8, multi-link 8 small vessel (sv) and multi-link long length (ll) coronary stent systems (css) instructions for use (ifu) states: when treating multiple lesions, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for dislodging the proximal stent.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation determined the reported difficulties and subsequent treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MULTI-LINK 8
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14672317
• MDR Text Key: 293848645
• Report Number: 2024168-2022-06291
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 1012165-38
• Device Lot Number: 1040141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: RYUREI BALLOON; UNSPECIFIED GUIDE WIRE
• Patient Outcome(s): Required Intervention