MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1011709-23

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Material Deformation (2976); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous, moderately calcified, and de novo lesion located in the mid left anterior descending artery.A 3.0 x 23 mm xience prime stent was removed from the box and there was slight resistance during uncoiling and when removing the protective sheath.There was a bulge on the sheath, and it was noticed the proximal and distal edges of the stent were flared, and the balloon was partially inflated.This stent was not used in the patient.An attempt was made to use a new 3.0 x 23 mm xience prime stent, but it could not cross due to the anatomy.The procedure was successfully completed with a 3.0 x 18mm xience prime stent.There were no adverse patient effects and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported product quality issue (partially inflated) was confirmed and the reported flared stent was not confirmed.The reported difficulty to remove (sheath) and physical property issue (bulged sheath) could not be confirmed since the sheath was not returned for analysis.Additionally, the reported difficulty to remove (hoop dispenser) could not be confirmed due to device condition.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7544819
• MDR Text Key: 109496916
• Report Number: 2024168-2018-03924
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Catalogue Number: 1011709-23
• Device Lot Number: 7081641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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