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

Catalog Number 1012167-15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

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 evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The other multilink 8 device referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was performed to treat a lesion in the right coronary artery (rca) with heavy calcification and heavy tortuosity.An unspecified extra support wire and a 3.0 x 08 mm non-compliant balloon catheter were advancing, but the balloon catheter could not cross the lesion.A 2.5 x 12 mm non-compliant balloon catheter was used instead and could reach the lesion, inflated three times at 14 and 20 atmospheres, to complete pre-dilatation.A 3.0 x 18 mm rx multi-link stent was advancing, but was not able to cross the lesion due to the heavy tortuosity and calcification.Force was applied and the shaft separated.The separated portion was removed from the patient.A second unspecified extra support wire was advanced to the distal portion of the posterior ventricular branch.A 3.0 x 15 mm rx multi-link stent was used, but was also not able to cross the lesion due the heavy tortuosity and calcification and the shaft separated.A new non-compliant 3.0 x 08 mm balloon catheter was advanced, inflated to 14 atmospheres for additional pre-dilatation.Then a non-abbott stent was deployed at 16 atmospheres to the mid portion of the rca to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual and dimensional inspection was performed on the returned device.The reported shaft detachment was 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 did not indicate a lot specific quality issue.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: 7632747
• MDR Text Key: 112320081
• Report Number: 2024168-2018-04908
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1012167-15
• Device Lot Number: 7061441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR