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

Catalog Number 1120300-18

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional xience xpedition device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a heavily tortuous, heavily calcified mid left anterior descending artery.The patient presented with unstable angina with very complex lesions.A 3.0 x 18 mm xience alpine stent delivery system (sds) was advanced to the distal part of the lesion and when inflated ruptured.Then a 3.0 x 23 mm xience alpine sds was advanced but a fracture was noted on the body of the device.A 3.0 x 18 mm unspecified stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Per reassessment of the initially filed mdr report, the 3.0x23mm xience device is a xience xpedition, not a xience alpine.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Mfr site: correction - (b)(6).Mfr site: correction - reg#.Evaluation summary: the device was returned for analysis.The reported material rupture was not confirmed.It should be noted that the xience alpine everolimus eluting coronary stent system instruction for use states: (delivery system preparation) to be performed prior to (delivery procedure).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 determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE ALPINE 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
• MDR Report Key: 8688626
• MDR Text Key: 147718059
• Report Number: 2024168-2019-04597
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2019
• Device Catalogue Number: 1120300-18
• Device Lot Number: 6092741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 109