MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 09/10/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is filed to report the patient death.It was reported that this was a mitraclip procedure to treat grade 3-4 functional mitral regurgitation (mr).Acute procedural success was achieved with the implantation of one mitraclip reducing mr to grade 1.It was then noted that the iliac vein ruptured.Treatment was performed with an occlusion balloon and a stent graft.The bleed appeared to have stopped.After the sheath was withdrawn, the blood pressure dropped and the patient went into cardiac arrest.Cardiopulmonary resuscitation was performed and pcps (percutaneous cardiopulmonary support) was inserted.The iliac vein was still bleeding.A long stent graft was implanted.Sinus rhythm returned, but the blood pressure was unstable.The patient was brought to the intensive care unit with pcps.In the opinion of the physician, when the 16 french sheath was inserted, resistance was met and insertion was done with excessive force, causing the iliac vein rupture.There were no device performance issues with the mitraclip.One day post procedure, the patient expired.Autopsy identified the cause of death as hematothorax due to cardiac massage.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effect of cardiac arrest appears to be the secondary effect of the iliac vein rupture and hemorrhage.The patient death was a consequence of the hemothorax.The reported patient effects of cardiac arrest and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• 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: 7918599
• MDR Text Key: 122031822
• Report Number: 2024168-2018-07500
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80523U228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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: MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 45