MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SC 3W HP RA OFF NB- OEM

Catalog Number	80055009
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2020 a surgeon was unable to fully deploy a sapien 3 trans catheter valve.It was stated by the reporter "the first valve was placed high/ over expanded as a result of a quick improvisation that occurred after the valve was not fully inflated.A second valve was implanted to fix the leak and stabilize the first valve." the reporter states, "it is not known where the source of the leak is." there was no serious injury reported.However, due to the reported nature of the incident and in abundance of caution this medwatch is being filed.The sample is not available for return and evaluation.No further information is available at this time.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported, there was a large column of air.A second valve was implanted to fix the leak and stabilize the first valve.
Event or Problem Description
It was reported, there was a large column of air.A second valve was implanted to fix the leak and stabilize the first valve.
Additional Manufacturer Narrative
B4: date of this report: 11/3/2020, corrected submission date is 11/3/2020.First attempted submission of 11/2/2020 was stuck "in processing" in web trader.G6 type of report: follow-up/01 h2 if follow-up, what type? correction.

• Common Device Name: SC 3W HP RA OFF NB- OEM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10777453
• Report Number: 3015910259-2020-00001
• Device Sequence Number: 2960337
• Product Code: DTL
• UDI-Device Identifier: 10193489066661
• UDI-Public: 10193489066661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 80055009
• Device Lot Number: 5565768, 5607041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 82