MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION MEDTRONIC HALL PROSTHETIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number M7700

Device Problems Calcified (1077); Perivalvular Leak (1457); Scratched Material (3020); Material Split, Cut or Torn (4008); Separation Problem (4043)

Patient Problems Host-Tissue Reaction (1297); No Information (3190)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately 16 years post implant of this mitral mechanical valve, approximately 1/3 of the prosthetic valve was detached from the valve annulus on the anterior apical side.As a result, paravalvular regurgitation was present.It was reported that the suture(s) had "snapped" near the area of detachment.The valve was explanted and replaced with a non-medtronic bioprosthetic valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Corrected implant date in d6, only year (2003) is valid.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Concomitant medical products: corrected return date h6: updated coding product analysis: upon receipt at medtronic's quality laboratory, visual inspection revealed that sutures remained attached to the sewing ring of the valve, except for one section where no sutures were present.That section of the sewing ring was damaged with a diagonal cut approximately 11mm in length.Remnants of pannus remained attached to the inflow and outflow portions of the sewing ring.Radiography revealed calcification on the sewing ring.The disc of the mechanical valve was intact with no visible damage.The disc rotated without and moved to fully open and close difficulty.The housing of the valve was intact with no evidence of damage.Surface scratches were observed on the housing orifice and structural member.It appeared that these scratches occurred during the explant procedure.Conclusion: a conclusive cause of the reported suture breakage and paravalvular leak (pvl) could not be determined.Sutures were missing from part of the sewing ring, and there was damage to the sewing ring itself.The damage to the ring however was a cut, which is unlikely to have occurred while the valve was implanted.These may be contributory causes to the pvl, but it cannot be confirmed.Other possible causes of pvl include: implant technique, valve positioning during implant, patient anatomy, or presence of pre-existing patient conditions.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: MEDTRONIC HALL PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8727363
• MDR Text Key: 148965974
• Report Number: 2025587-2019-02014
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P060025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M7700
• Device Catalogue Number: M7700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR