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

Catalog Number CDS0601-XTR

Device Problem Incomplete Coaptation (2507)

Patient Problems High Blood Pressure/ Hypertension (1908); Neurological Deficit/Dysfunction (1982); Tissue Damage (2104)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 from this lot.The reported patient effect of mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported single leaflet device attachment (slda) and tissue damage could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

This is filed for single leaflet device attachment (slda) and tissue damage.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.One clip was implanted without issue and mr was reduced to grade 2+.Final echocardiogram was performed and noted a large mr jet.It could not be confirmed if it was due to an slda at the posterior leaflet or a posterior leaflet tear.Mr increased to grade 4+.One additional clip was implanted, medial to the first, to stabilize the detached clip and mr was reduced to grade 3.Post procedure, the patient was in stable condition.No additional information was provided.

Manufacturer Narrative

(b)(4).The reported patient effect of hypertension as listed in the mitraclip ntr/xtr system instructions for use is a known possible complication associated with mitraclip procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.

Event Description

Subsequent to the initial 30-day medwatch report, additional information was received, indicating that during the index procedure, after the clip was implanted and before the patient was extubated, the patient became agitated and an increase in blood pressure was noted.The single leaflet device attachment was noted.A second clip was implanted and the mr was reduced to grade 3+.No additional information was provided.

• Brand Name: MITRACLIP XTR 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: 8553003
• MDR Text Key: 143228785
• Report Number: 2024168-2019-03311
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90221U122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 76