MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0201

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient the clip delivery system was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the increased mitral regurgitation (mr) with possible clip movement and tissue damage.It was reported that this was a mitraclip procedure on (b)(6) 2016 to treat degenerative mr with a grade of 4.Two clips ((b)(4)) were implanted reducing mr grade to 2.On (b)(6) 2018, the patient presented in the office symptomatic with increased dyspnea with daily activities.A transthoracic echocardiogram (tte) was performed and it was found that the mr had increased to 4.The patient refused a transesophageal echocardiogram (tee); therefore, it could not be determined if this was due to progression of disease or possible movement of clip / chordal damage.There was no treatment performed and no hospitalization.No additional information was provided.

Manufacturer Narrative

(b)(4).It could not be confirmed which implanted clip had the possible clip movement; therefore, the lot history record (lhr) and complaint history risk assessment was performed on both clips.The results are as follows: part / lot: cds0201/60203u101, date of manufacture: 03-feb-2016, expiration date: 28-feb-2017.Part / lot: cds0201/60401u202, date of manufacture: 04-apr-2016, expiration date: 30-apr-2017.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lots that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and a definitive cause for the partial clip movement in this incident could not be determined.Additionally, a definitive cause for the reported tissue damage, dyspnea and recurrent mitral regurgitation (mr) could not be determined.The reported patient effects of dyspnea, recurrent mr, and tissue damage as listed in the mitraclip system instructions for use, are known possible complication associated with mitraclip procedures.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7626622
• MDR Text Key: 111935906
• Report Number: 2024168-2018-04793
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 1 ADDITIONAL IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 86