MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/26; COVERED CORONARY STENT

Model Number	434899
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Death
Event or Problem Description
It was attempted to treat a perforation with the pk papyrus stent system but it did not seal the distal perforation properly.Thus another stent was deployed inside the pk papyrus and sealed the perforation.
Additional Manufacturer Narrative
30-nov-2020 - additional information received: the pk papyrus stent system was chosen for the treatment of a type iii coronary artery perforation after atherectomy.Overall it was decided to place six stents.After placing the first two stents it was decided to place and deploy the pk papyrus 3.0/26 stent system more distally but it did not seal the perforation properly.Thus another stent was deployed inside the pk papyrus.However the patient suffered a cardial tamponade and died day of procedure, (b)(6) 2020, but not related to device.
Additional Manufacturer Narrative
(b)(6) 2020 - additional information received: the pk papyrus stent system was chosen for the treatment of a type iii coronary artery perforation after atherectomy.Overall it was decided to place six stents.After placing the first two stents it was decided to place and deploy the pk papyrus 3.0/26 stent system more distally but it did not seal the perforation properly.Thus another stent was deployed inside the pk papyrus.However the patient suffered a cardial tamponade and died day of procedure, (b)(6) 2020, but not related to device.Neither the complaint instrument nor the angiographic material was returned for analysis.The affected stent was implanted in the target lesion.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections during which a 100 percent control of the stent cover is performed.Based on the conducted investigations, no manufacturing or material related root cause could be identified.

• Brand Name: PK PAPYRUS US 3.0/26
• Common Device Name: COVERED CORONARY STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10606228
• Report Number: 1028232-2020-04177
• Device Sequence Number: 16811881
• Product Code: NIV
• UDI-Device Identifier: 07640130447271
• UDI-Public: 07640130447271
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 434899
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09192034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 11/30/2020; 12/22/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/30/2020; 12/22/2020
• 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: Death; Hospitalization
• Patient Age: 83 YR