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

Catalog Number 1012167-28

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: guide wire: fielder fc, stent: 3.0 x 38 mm multi-link 8.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The 3.0 x 38 mm rx multi-link 8 is being filed under separate medwatch report.

Event Description

It was reported the procedure was performed to treat a de novo lesion with moderate tortuosity, mild calcification, 99% stenosis and thrombus in the proximal to mid right coronary artery (rca).The patient presented with acute myocardial infarction (ami).A thrombectomy device was used to aspirate the thrombus.Pre-dilatation was performed and a 3.0 x 38 mm multi-link stent was deployed in the middle section of the lesion.A 3.0 x 28 mm multi-link stent delivery system (sds) was advanced to the proximal section of the lesion.When an attempt was made to deploy the stent overlapping with the distal stent implant, the stent got caught with the implanted stent.The 3.0 x 28 mm multi-link sds was withdrawn, but because the stent was caught within the first stent implant, the 3.0 x 38 mm multi-link stent implant (first) elongated and was explanted, and the 3.0 x 28 mm multi-link stent dislodged.A snare device was used to retrieve the two stents.A 3.0 x 38 mm multi-link 8 and a 3.0 x 28 mm multi-link stents were used to complete the procedure successfully.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The investigation determined that the reported difficulties and subsequent treatments appear to be related to circumstances of the procedure.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.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 7399920
• MDR Text Key: 104522332
• Report Number: 2024168-2018-02506
• 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: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• 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: 1012167-28
• Device Lot Number: 5121741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 63 YR
• Patient Weight: 72