MAUDE Adverse Event Report: AV-TEMECULA-CT ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

Catalog Number 1003382-18

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Medical devices: stent: 4.0 x 23 mm vision.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous chronic total occlusion of the right coronary artery.Thrombectomy was done and a 4.0 x 23 mm vision stent was implanted in the mid right coronary artery.Then, an attempt was made to implant a 5.0 x 18 mm ultra 9-cell stent proximally to the vision stent.However, the ultra 9-cell stent advanced too far and the stent dislodged from the balloon of its stent delivery system.Therefore, the ultra 9-cell stent migrated downwards to the posterior descending artery and the stent was crushed in this artery by a non-abbott balloon dilatation catheter.Then a 5.0 x 13 mm ultra 9-cell stent was advanced towards the right coronary artery; however, the stent was too bulky and it failed to cross the lesion due to the anatomy.Therefore, a 4.5 x 18 mm and a 4.5 x 13 mm ultra 9-cell stent were implanted to successfully complete the procedure.Timi 3 flow was achieved.There was no adverse patient sequela reported.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
• 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: 7288804
• MDR Text Key: 100694134
• Report Number: 2024168-2018-01302
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1003382-18
• Device Lot Number: 6120841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 84