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

Catalog Number	1550225-15
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.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.The investigation determined that the reported failure to advance, difficulty to remove and stent dislodgement appear to be related to circumstances of the procedure as interactions with the patient stiff, heavily tortuous, heavily calcified, 80% stenosed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a stiff, heavily tortuous, heavily calcified, 80% stenosed lesion in the proximal to distal left anterior descending (lad) coronary artery.Pre-dilatation was performed with an unspecified balloon dilatation catheter (bdc).A 2.25 x 15 mm xience sierra rx stent delivery system (sds) was then advanced and was unable to reach the distal end of the lesion.During sds removal from the patient anatomy, the xience sierra stent got caught on heavy calcium and dislodged in the proximal to mid portion of the target lesion.An unspecified bdc was then advanced to the dislodged stent, and inflated to deploy the stent in the proximal to mid portion of the target lesion.Following additional pre-dilatation, attempts were made to treat the lesion with three different stents, but nothing would cross, so the procedure was aborted.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7759143
• Report Number: 2024168-2018-06066
• Device Sequence Number: 1258430
• Product Code: NIQ
• UDI-Device Identifier: 08717648227011
• UDI-Public: 08717648227011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2019
• Device Catalogue Number: 1550225-15
• Device Lot Number: 8032642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 103