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

Catalog Number 1012378-12

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.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 a de novo lesion in the moderately tortuous, heavily calcified, 90% stenosed coronary artery.Resistance was noted during advancement of the 3.0 x 12 mm multi-link 8 stent delivery system (sds), and blood was noted in the device.The sds, including the stent, was removed without issue.The procedure was completed with balloon angioplasty.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, it was noted that device preparation was performed in the patient anatomy.No additional information was provided.

Manufacturer Narrative

Device codes: 2017 labeled internal file number: (b)(4).Device code 2017: incorrect device preparation.Evaluation summary: a visual, functional and dimensional inspection was performed in addition to a chemical analysis on the returned device.The reported leak was confirmed.The reported physical resistance could not be tested as it was based on operational circumstances.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.It should be noted that the multi-link 8 coronary stent systems (css) instructions for use (ifu), instructs to purge all air from the device prior to use.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure, as it is likely the device interacted with the moderately tortuous, heavily calcified, 90% stenosed coronary artery during advancement, as resistance was noted, resulting in the reported physical resistance.Further manipulation of the device in addition to interaction with the anatomy likely contributed to the noted tear on the outer member at the mid lap seal, resulting in the reported leak.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
• MDR Report Key: 8656791
• MDR Text Key: 146680121
• Report Number: 2024168-2019-04255
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• PMA/PMN Number: P020047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1012378-12
• Device Lot Number: 7082841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1