MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 5/120/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366814

Device Problem Material Deformation (2976)

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

Event Date 05/17/2019

Event Type  malfunction  

Event Description

A pulsar-18 was chosen to treat a calcified lesion in a tortuous left sfa.After deployment the stent looked crushed.Despite post-dilatation the angiographic images showed a deranged stent.A second stent was placed inside the defected area with good result.

Manufacturer Narrative

The complaint instrument was not returned to biotronik.Therefore no technical investigation on the subject could be performed.The corresponding production documentation as well as low resolution pictures taken from the angiographic images were reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In the pictures taken from the angiographic images geometric distortions of the stent structure are visible.The inhomogeneous radiopacity along the stent length may be suggestive of stent compression.The review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations, no manufacturing related root cause could be determined.It therefore seems likely that the root cause for the complaint event is related to external factors during the procedure.However, it should be noted that, according to the ifu, placement of the pulsar-18 stent in the popliteal artery is contraindicated.

• Brand Name: PULSAR-18 5/120/90
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 8689246
• MDR Text Key: 147727477
• Report Number: 1028232-2019-02327
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Model Number: 366814
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05185524
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1