MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI MED 25 POUCHES WITH 24 CLIPS; CLIP, IMPLANTABLE

Model Number IPN914926

Device Problem Difficult to Open or Close (2921)

Patient Problem Unspecified Heart Problem (4454)

Event Date 09/19/2022

Event Type  Death  

Event Description

It was reported "[one] fully dislocated clip leading to rethoracotomy, after harvesting the vein graft 1/3 of the clips not fully occlusive." additional information received stated "there were 3 bypasses made with a vein from the leg.There were around 10 clips on the side branches of those veins.One was totally off and the two or three were still on the side branches but seemed to be not fully closed; still dry but not totally closed".It was described that after two hours after wound closure, a repeat thoracotomy was prompted due to "big bleeding, drain full of blood, and very low blood pressure." patient condition was reported as expired.

Manufacturer Narrative

Qn# (b)(4).A device history record review could not be conducted since the lot number was not provided at the time of this report.A follow-up report will be issued after the investigation is complete.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product horizon ti med 25 pouches with 24 clips lot# 73k2100639 was manufactured on 10/18/2021 a total of (b)(4) pieces.Lot was released on 11/01/2021.Dhr investigation did not show issues related to complaint.The device was investigated by the engineer, and it was reported that the customer returned sixty unopened representative samples of (b)(6) horizon ti med 25 pouches with 24 clips for investigation.The actual sample was not returned.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the clips appear typical.No defects or anomalies were observed.The applier associated with the reported failure was not returned.Functional inspection was performed on the returned representative samples.A lab inventory clip applier was used.All clips from each representative sample were able to properly load into the applier.The clips were able to close properly when applied to over-stressed surgical tubing.No functional issues were found with the returned clips.However, no root cause could be determined since the actual samples (the clips that failed) were not returned.It is possible the root cause is related to the applier that was used if the applier was misaligned or damaged which could prevent the clips from closing properly on the vessel.However, this could not be determined since the applier was not returned.The ifu for this product, l02428 rev 02, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." the reported complaint of "ligation failure-clip not closing " could not be confirmed based on the returned samples.Sixty representative samples were returned.Upon functional inspection, no problems were found as clips could be loaded into the jaws of a lab inventory applier and properly close when applied to over-stressed surgical tubing.No functional issues were found with the returned clips.However, no root cause could be determined since the actual samples (the clips that failed) were not returned.It is possible the root cause is related to the applier that was used if the applier was misaligned or damaged which could prevent the clips from closing properly on the vessel.However, this could not be determined since the applier was not returned.The ifu for this product instructs the user to "always check the alignment of the applier jaws before use.".

Event Description

It was reported "[one] fully dislocated clip leading to rethoracotomy, after harvesting the vein graft 1/3 of the clips not fully occlusive." additional information received stated "there were 3 bypasses made with a vein from the leg.There were around 10 clips on the side branches of those veins.One was totally off and the two or three were still on the side branches but seemed to be not fully closed; still dry but not totally closed".It was described that after two hours after wound closure, a repeat thoracotomy was prompted due to "big bleeding, drain full of blood, and very low blood pressure." patient condition was reported as expired.

• Brand Name: HORIZON TI MED 25 POUCHES WITH 24 CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15672526
• MDR Text Key: 302401902
• Report Number: 3003898360-2022-00565
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704696315
• UDI-Public: 34026704696315
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN914926
• Device Catalogue Number: 002204
• Device Lot Number: 73K2100639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening; Death
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 71 KG