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

Catalog Number CDS0201

Event Date 09/29/2017

Event Type  Death  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event, implant date - estimated. Due to system limitations, the type of report is selected as 30 day although this is a periodic report. Pas1 and pas2 mitraclip post approval study data is reported as a summary per summary reporting exception approval number (b)(4). The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

Event Description

Per the requirements of the post approval study 1 (pas1) and pas2, post approval mitraclip studies conducted via the tvt registry, abbott has received data downloaded from the center for medicare and medicaid services (cms) claims database for patients in the studies. The data contained 347 death events. The relationship of the deaths to the mitraclip device cannot be determined based on the data received; therefore, abbott vascular is conservatively reporting these events. The data are reported as a summary report per summary reporting exemption approval number (b)(4).

Manufacturer Narrative

(b)(4). The device was not returned for analysis. Additionally, a review of the lot history records could not be conducted, because the lot numbers were not provided. The reported patient effect of death as listed in the mitraclip system electronic instructions for use, is a known possible complication associated with mitraclip procedures. Based on the information reviewed, 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: 7211243
• Report Number: 2024168-2018-00520
• Device Sequence Number: 1
• Product Code: NKM
• Report Source: Manufacturer
• Reporter Occupation: HEALTH PROFESSIONAL
• Remedial Action: Other
• Report Date: 02/13/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/22/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: CDS0201
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/12/2018
• 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 TREATMENT DATA

Date Received: 01/22/2018 Patient Sequence Number: 1