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

Catalog Number 1012167-28

Device Problems Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

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 is expected to be returned for investigation.It has not yet been received.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 located in the heavily calcified, mildly tortuous, 95% stenosed proximal left anterior descending artery.Pre-dilatation was performed with dilatation balloons (1.5x8 mm, 2x20 mm and 3x15 mm).An attempt was made to cross the lesion with the 3.0 x 28 mm multi-link 8 stent delivery system; however, during the attempt to cross resistance was felt and the proximal shaft kinked and then separated.The device was retrieved from the patient without issue.No adverse patient effect or clinically significant delay in the procedure was reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported shaft kink and detachment of the device (shaft separation) were confirmed.The reported failure to advance 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.The investigation determined that 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.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported shaft kink and detachment of the device (shaft separation) were confirmed.The reported failure to advance 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.The investigation determined that 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: 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: 7635003
• MDR Text Key: 112568280
• Report Number: 2024168-2018-04967
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1012167-28
• Device Lot Number: 6121541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Date Manufacturer Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1