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

Catalog Number 1009532-23

Device Problems Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat de novo lesions in the mid left anterior descending (lad) artery and mid left circumflex (lcx)artery.Mild tortuosity and mild calcification was reported for the lad and mild tortuosity and heavy calcification was reported for the lcx.A 2.25 x 23 mm xience v rx stent delivery system (sds) was advanced to the lcx lesion and met resistance with the calcification which caused the stent to dislodge from the balloon.The dislodged stent was deployed outside of the lesion in healthy tissue using another balloon dilatation catheter (bdc).During the same procedure, a 2.25 x 15 xience v rx sds was advanced to the lad but would not cross it due to the anatomy.No further attempts were made, instead the patient was left on medical management.No additional information was provided.

Manufacturer Narrative

(b)(4).It was initially reported that the device would be returned for analysis; however, the device was not returned.The device was not returned for analysis.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the heavily calcified anatomy resulting in the reported failure to advance and ultimately resulting in the reported stent dislodgement.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 did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE V 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: 6411996
• MDR Text Key: 70174036
• Report Number: 2024168-2017-02226
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

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: Health Professional
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 1009532-23
• Device Lot Number: 6102641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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