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

Catalog Number	CDS0201
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional 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 evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported patient effect.A conclusive cause for the reported patient effects of air embolism and cerebrovascular accident and the relationship to the device, if any, cannot be determined.The reported hospitalization was a result of case-specific circumstances, as the patient was hospitalized due to the stroke.The reported patient effects of stroke or transient ischemic attack (cerebrovascular accident) and air embolism, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, there is no indication of a product quality issue.
Event or Problem Description
This is filed to report stroke and possible air embolism.It was reported that the initial mitraclip procedure was performed on (b)(6) 2017, to treat degenerative mitral regurgitation (mr) with a grade of 4+.Two clips were implanted, reducing the mr to 2.There was no issue noted during the procedure.On (b)(6) 2017, the patient experienced a stroke and was hospitalized.No further treatment has been planned.The cause of the stroke is unknown; however, the physician suspects that a possible air embolism occurred during the mitraclip procedure.The patient is currently stable.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6547770
• Report Number: 2024168-2017-03953
• Device Sequence Number: 533273
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914(17)170726(10)60726U112
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2017
• Device Catalogue Number: CDS0201
• Device Lot Number: 60726U112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONE ADDITIONAL IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Weight: 48