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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/26; COVERED CORONARY STENT
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BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/26; COVERED CORONARY STENT Back to Search Results
Model Number 434900
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/30/2021
Type of Reportable Event Malfunction
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of a perforation in the rca.During pre-dilatation of the lesion several balloons ruptured but a drug eluting stent could be subsequently implanted.During post-dilatation the perforation was detected.The perforation was tamponade with a balloon for 5 min.Subsequently, the pk papyrus was delivered but did not advance across the perforated segment, stripped of the balloon and was deployed proximal to the perforation.Another pk papyrus was implanted and the perforation was sealed.Patient remained stable.
 
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Brand Name
PK PAPYRUS US 3.5/26
Common Device Name
COVERED CORONARY STENT
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
MDR Report Key11856228
Report Number1028232-2021-02736
Device Sequence Number19582002
Product Code NIV
UDI-Device Identifier07640130447288
UDI-Public07640130447288
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
H170004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/06/2021
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 Expiration Date09/30/2021
Device Model Number434900
Device Catalogue NumberSEE MODEL NO.
Device Lot Number09195554
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/06/2021
Supplement Date Received by Manufacturer06/29/2021
Initial Report FDA Received Date05/20/2021
Supplement Report FDA Received Date06/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age54 YR
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