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

Catalog Number 1125250-28

Device Problems Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problems Angina (1710); Myocardial Infarction (1969); Stenosis (2263)

Event Date 01/17/2019

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 investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous and moderately calcified proximal left anterior descending artery (lad).On (b)(6) 2018, the patient presented with shock due to acute coronary syndrome (acs).Therefore, a 2.5 x 28 mm xience alpine stent was implanted in the proximal lad and a non-abbott stent was implanted in the left main.Stent apposition in the proximal lad was not confirmed with intravascular ultrasound (ivus).Then, on (b)(6) 2019, the patient presented with angina; therefore, isosorbide dinitrate sublingual tablet was administered.Angiography revealed restenosis in the proximal lad, and optical coherence tomography (oct) revealed that the distal part of the xience alpine stent in the proximal lad was not dilated at all.Additionally, a myocardial infarction was diagnosed.Therefore, an unspecified 2.75 mm and 3 mm nc balloon catheter were used to dilate the distal part of the stent.However, the stent would not dilate.An atherectomy device was then advanced through the stent to facilitate dilatation.However, the atherectomy device became stuck with the stent.The atherectomy device was then removed from the anatomy.Angiography then revealed that both the xience alpine and the non-abbott stent were removed from the anatomy.Pre-dilatation was then performed and an atherectomy device was used.Two non-abbott stents and an unspecified xience sierra stent were implanted in the left main and the proximal lad to successfully complete the procedure.Medication was administered.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial report, additional information was received.The 2.5 x 28 mm xience alpine stent was well apposed to the vessel wall and this was confirmed via angiography and intravascular ultrasound (ivus).No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: device code 1157 was removed.Evaluation summary: the device was returned for analysis.The reported difficulty to position and device damaged by another could not be replicated in a testing environment as it was based on circumstances 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 reported patient effects of angina, stenosis, and myocardial infarction are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects of angina, stenosis and myocardial infarction, and the relationship to the product, if any, cannot be determined.Additionally, the investigation determined the reported difficulties are related to operational context of the procedure.The atherectomy device interacted with the stent and was stuck together with the stent causing the reported difficulty to position (crossibility).The atherectomy device was then removed, the stent remained stuck together with the device causing the reported device damaged by another and removal of stent from the anatomy.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: 8325932
• MDR Text Key: 135722094
• Report Number: 2024168-2019-01030
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: 1125250-28
• Device Lot Number: 7032241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATHERECTOMY:DIAMONDBACK,ROTABLATOR, STENT:SYNERG
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 78 YR
• Patient Weight: 61