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

Model Number T505C

Device Problems Incomplete Coaptation (2507); Device Packaging Compromised (2916)

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

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, however, the return is anticipated.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.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.

Event Description

Medtronic received information that immediately following implant of this bioprosthetic valve, it was explanted and replaced due to dryness and lack of leaflet motion.Upon removal, it was discovered that there was no formalin and the valve storage bottle was cracked and dried.No adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device was not returned for analysis at this point.Without the return of the device, the alleged issue cannot be confirmed.There was insufficient information to determine a conclusive root cause at this time.Per medtronics procedure, jar check was performed after packaging the product and before vacuum testing.The jar and lid were examined for damaged (i.E.Chips, cracks etc.).Also, proper threading of each jar and lid were inspected.The device history record was also reviewed and shows that this valve met all manufacturing specifications for product released to distribution.Exactly what caused (when and how) the jar leak cannot be determined; however during inspection of the final packaging at medtronic, the jar was filled.Also, the packaging configuration was subjected to package validation testing.Therefore, it was likely that if any damage occurred that would be outside of medtronics control.The leaflet motion issue of the valve most likely is due to the leak of the storage solution and caused the tissue dry out.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

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

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The jar did not contain any fluid.The outer packaging box appeared dry with brown watermarks observed on the side.Amber colored watermarks were also observed in the inner carton and on the pages of the ¿device registration and tracking¿ envelope.The threads on the jar showed no damage, except for a broken piece.The threads on the jar lid appeared damage free.Large cracks were observed along the jar.The valve was received desiccated.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.Per medtronic¿s procedure, jar check was performed after packaging the product and before vacuum testing.Using detailed inspection techniques, the jar and lid, including the threading, were examined for damage (i.E.Chips, cracks etc.).The analysis confirmed a large crack along the wall of the jar.Based on this observation, it suggested that the jar cracked/broke on impact.At this time, there is insufficient information to determine a conclusive root cause.Exactly what caused (when and how) the jar broke cannot be determined; however during 100 percent inspection of the final packaging at medtronic, the jar was not broken.Also, the packaging configuration was subjected to package validation testing per astm d4169 (2009), standard practice for performance testing of shipping containers and systems.Therefore, it was very likely that if any damage occurred that would be outside of medtronic¿s control.

Manufacturer Narrative

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: 5756403
• MDR Text Key: 48374604
• Report Number: 2025587-2016-00947
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2018
• Device Model Number: T505C
• Device Catalogue Number: T505C221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2013
• 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: 58 YR
• Patient Weight: 56