MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 505U

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2017

Event Type  Injury  

Event Description

Medtronic received information that upon implant of this bioprosthetic valve, the surgeon observed a small hole in one of the leaflets.This hole reportedly had not been visible to the surgeon prior to implant and it was not believed to have been caused by suturing.The device was explanted and replaced successfully and no other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.All leaflets were in the closed position.Two cuts through the tunica of the right cusp were observed.The 4mm and 5mm cuts appeared consistent with a puncture or laceration by a sharp instrument such as forceps or scalpel.A tear between the cuts was observed.All commissures were intact.The right noncoronary commissure (nrc) post was relaxed due to a broken suture.The broken suture tips were found tucked in the nrc post and within the sewing ring adjacent to the right cusp (rc).Under magnification, the tips of the sutures were observed.Both suture tips were frayed/jagged not smooth, indicating they were broken rather than cut.A small smooth indentation was observed on one of the suture tips.Its smooth appearance suggests damaged due to a sharp object.As received, the valve holder was activated as the left right commissure (lrc) and noncoronary left commissure (nlc) posts were deflected.Scrape like damage and indentations were observed on top of the holder, possibly caused by sharp object such as forceps.The same scrape-like damage and indentations was noted on both sides of the holder leg adjacent to the rc.The device was inspected by a manufacturing engineer during product analysis.It was confirmed that these observed damages on the leaflet, suture and holder could not have been made during the manufacture of the device and its components.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The observations of the cuts were appeared to be consistent with a puncture or laceration by a sharp instrument such as forceps during implant.Per medtronic procedure each hancock ii valve was 100 percent inspected during final inspection on tissue characteristics and damages.In addition, the valve holder suture was broken and the valve holder was damaged; these additional observations also appeared to be consistent with damage by a sharp instrument such as forceps during implant or explant (removed the holder from the handle).Based on the received information and analysis results of the returned device, the clinical observations, tear, was confirmed.The cause of the tear could be related to the implant procedure contact with a sharp instrument.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6569262
• MDR Text Key: 75258040
• Report Number: 2025587-2017-00808
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2019
• Device Model Number: 505U
• Device Catalogue Number: T505U223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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: 73 YR
• Patient Weight: 66