MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1550300-28
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, moderately calcified, 90% stenosed lesion in the mid-left anterior descending coronary artery.The vessel was not pre-dilatated.The 3.0 x 28 mm xience sierra stent delivery system (sds) was advanced; however, resistance was felt with the anatomy.The stent was deployed and was post dilated three times at 12 atmospheres.While the sds was being removed, blood was observed in the device.It suspected the balloon ruptured during the third inflation.The sds was removed without issue.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported material rupture was confirmed.The reported difficulty to advance could not be confirmed as it was related to operational context of the 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 difficulty to advance appears to be related to circumstances of the procedure as it is likely the device interacted with the difficult lesion causing the reported difficulty to advance.The investigation was unable to determine a conclusive cause for the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8872016
• Report Number: 2024168-2019-10667
• Device Sequence Number: 1828399
• Product Code: NIQ
• UDI-Device Identifier: 08717648227288
• UDI-Public: 08717648227288
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2021
• Device Catalogue Number: 1550300-28
• Device Lot Number: 8121141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1