MAUDE Adverse Event Report: MEDINOL LTD. ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number 2.75X12

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

For dec.13, 2017: "we had a dislodgement in (b)(6) on monday.A 2.75x12 elunir was dislodged while passing through another elunir (3.5x20, implanted just before).According to the distributor's representative, the physician did not report any resistance while it happened, but the delivery system moved forward while the stent dislodged.The dislodged stent was then crushed by opening another stent at the same location.I requested that the distributor fill form 081101" for dec.17, 2017: short description: failure to cross; tracking difficulty through another stent; stent dislodgement during retrieval into guide inside patient.Description: stent (elunir 2.75 x 12 mm) dislodgement off balloon inside patient while the system was passing through another stent (side branch).Patient condition: no harm to patient.Location of the lesion: lad proximal; lad middle; first diagonal.Lesion/vessel calcification: low.Number of stents deployed: 3+1.Pre-dilatation pressure: 24-26 with nc balloon.Stent dilation pressure: 12-13.Which system actually crossed the lesion: other marketed product.

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Information received on jan.03, 2018 from medinol's distributor in (b)(4): · stent dislodged while the elunir system was passing through another stent.

• Brand Name: ELUNIR¿ RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• Manufacturer (Section G): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• Manufacturer Contact: marina tikhonov demishtein ; kiryat atidim, bldg. 8; tel aviv, 61581-01 ; IS 6158101
• MDR Report Key: 7163225
• MDR Text Key: 97582440
• Report Number: 3003084171-2018-00001
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/30/2019
• Device Model Number: 2.75X12
• Device Catalogue Number: LUN275R12IN
• Device Lot Number: LNRIN00015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2017
• 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