MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 10/16/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Date of implant has been estimated.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that a patient implanted with an unknown absorb had developed in-scaffold thrombosis post procedure and was treated at another hospital.Per the physician, a possible reason for the thrombosis might be because the vessel was almost 4 mm in diameter; however, the absorb scaffold implanted was only 3 mm in diameter.No additional information was provided.

Manufacturer Narrative

(b)(4).Date of event estimated as 1 week post procedure.(b)(4).Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.The reported patient effects of myocardial infarction and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.It should be noted that the ifu states: the absorb bvs is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Case details updated based on additional information received: it was reported that the patient presented with unstable angina.The index procedure on (b)(6) 2013 was to treat restenosis in an unspecified metallic stent located in the circumflex (cx) vessel.Vessel sizing was done using intravascular ultrasound (ivus).Predilatation was performed with an unspecified non-compliant (nc) balloon at nominal pressure to the absorb scaffold diameter with no residual stenosis.An unknown absorb scaffold was implanted to treat the restenosis.Post-dilatation was performed with an unspecified nc balloon at nominal pressure.Ivus was used to confirm that the scaffold was fully apposed to the vessel wall.The patient was administered dual anti-platelet therapy (dapt) consisting of plavix and polocard during their hospitalization.One week post procedure, the patient presented at a different hospital with a myocardial infarction and subsequently in-scaffold thrombosis was identified.Balloon angioplasty was performed to treat the thrombosis.Per the physician, a possible reason for the thrombosis might be because the vessel was almost 4 mm in diameter; however, the absorb scaffold implanted was only 3 mm in diameter.Additionally, the physician thinks the patient may not have been compliant with their dapt after the procedure.The patient was placed on dapt again.No additional information was provided.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6215790
• MDR Text Key: 63650670
• Report Number: 2024168-2016-09393
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 60